Fully integrated, disposable tissue visualization device

ABSTRACT

The present invention relates to a fully integrated sterilizable one time use disposable tissue visualization device and methods for using such devices. Preferred embodiments of the invention facilitate the visualization of an internal tissue site while causing a minimum of damage to the surrounding tissue. Further preferred embodiments may allow for the delivery of fluids and other treatment to an internal tissue site.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/234,999, filed Aug. 11, 2016, entitled FULLY INTEGRATED, DISPOSABLETISSUE VISUALIZATION which claims the benefit of U.S. ProvisionalApplication No. 62/203,898, filed Aug. 11, 2015, entitled FULLYINTEGRATED, DISPOSABLE TISSUE VISUALIZATION DEVICE. The contents of theaforementioned applications are hereby incorporated by reference intheir entireties as if fully set forth herein. The benefit of priorityto the foregoing applications is claimed under the appropriate legalbasis, including, without limitation, under 35 U.S.C. § 119(e).

BACKGROUND OF THE INVENTION Field of the Invention

This application describes embodiments of apparatuses, methods, andsystems for the visualization of tissues.

Description of the Related Art

Traditional surgical procedures, both therapeutic and diagnostic, forpathologies located within the body can cause significant trauma to theintervening tissues. These procedures often require a long incision,extensive muscle stripping, prolonged retraction of tissues, denervationand devascularization of tissue. Such procedures can require operatingroom time of several hours followed by several weeks of post-operativerecovery time due to the destruction of tissue during the surgicalprocedure. In some cases, these invasive procedures lead to permanentscarring and pain that can be more severe than the pain leading to thesurgical intervention.

The development of percutaneous procedures has yielded a majorimprovement in reducing recovery time and post-operative pain becauseminimal dissection of tissue, such as muscle tissue, is required. Forexample, minimally invasive surgical techniques are desirable for spinaland neurosurgical applications because of the need for access tolocations within the body and the danger of damage to vital interveningtissues. While developments in minimally invasive surgery are steps inthe right direction, there remains a need for further development inminimally invasive surgical instruments and methods.

Treatment of internal tissue sites, such as the treatment of anorthopedic joint, often requires visualization of the target internaltissues. However, proper visualization of an internal tissue site can beexpensive and time-consuming to schedule, such as when magneticresonance imaging (MRI) is required. Further, other modes of imaging canpotentially damage the tissue site, leading to poor diagnosis andextended recovery time. Consequently, there is need for improved devicesand methods for visualization of an internal tissue site.

SUMMARY OF THE INVENTION

Embodiments of the present invention relate to tissue visualizationdevices, methods, and systems. In some embodiments, tissue visualizationdevices comprise a visualization sensor and an elongated body having aproximal end and a distal end. The distal end of the elongated body maybe dimensioned to pass through a minimally invasive body opening. Incertain embodiments, the devices further comprise an integratedarticulation mechanism that imparts steerability to at least one of thevisualization sensor and the distal end of the elongated body. Furtherembodiments provide for methods of modifying the internal target tissuesof a subject using tissue modification devices.

One preferred implementation of the invention is a fully integratedsterilizable disposable tissue visualization device. The devicecomprises a handle, and an rigid elongated body extending along alongitudinal axis between a proximal end affixed to the handle and adistal end having a sharpened tip. An image sensor is provided in thehandle, and an elongate optical element extends through the probe, theoptical element having a proximal end in optical communication with thesensor, and having a distal end.

A control is provided on the handle, for axially moving the elongatedbody between a proximal position in which the sharpened tip is proximalto the distal end of the optical element, and a distal position in whichthe sharpened tip is distal to the distal end of the optical element.

An electrical cord may be integrally connected to the handle, having afree end with a connector for releasable electrical connection to anexternal viewing device.

The integral assembly of the handle, probe and cord may be sterilizedand packaged in a single sterile container. This enables opening of thesterile container within a sterile field in a clinical environment,plugging the cord into a compatible external viewing device, andcommencing a procedure on a patient without any additional assemblysteps.

The distal end of the elongated body may be provided with a lateraldeflection. The deflection may be in a first direction relative to thelongitudinal axis, and the cord is attached to the handle at a seconddirection relative to the longitudinal axis, and approximately 180°offset from the first direction. This provides visual and/or tactilefeedback of the direction of the distal lateral deflection. Proximalretraction of the elongated body deflects the distal end of the opticalelement laterally by at least about 1°, in some embodiments at leastabout 2 or 3 or 5° or more to enhance the field of view. In certainembodiments, rather than a lateral deflection at the distal end of theelongated body, the entire elongated body may be physically bent,providing a curve in the elongated body. Such a curve may have a degreeof curvature of approximately at least 0-5°, 5-10°, 10-20°, 20-40°,40-60°, 60-90°, or greater than 90°.

The optical element may comprise at least 1 and typically a plurality ofoptical visualization fibers and a distal lens. The optical element mayadditionally comprise at least one and typically a plurality ofillumination optical fibers. The optical visualization fibers, opticalillumination fibers and lens may be contained within a tubular body suchas a hypotube.

The optical element may have an outside diameter that is spaced radiallyinwardly from an inside surface of the elongated body to define anannular lumen extending the length of the elongated body. The lumen maybe in communication with an injection or an aspiration port on thehandle such as for infusion of a media such as an irrigant or activeagent, or for aspiration.

In one implementation of the invention, the device comprises anelongated body comprising a 14 gauge needle (2.1 mm Outer Diameter) orouter tubular body having a sharpened distal tip. An optical hypotube isaxially moveably positioned within the outer tubular body, such that itmay be moved from a distal position in which it extends beyond thesharpened tip and a proximal position in which the sharpened tip isdistally exposed. In certain embodiments, the optical hypotube maycomprise a distal lens, image guide comprising a multi-element fiber,and additional illumination fibers all contained within a hypotube. Theimage guide may contain any number of suitable elements, such as 10,000elements (e.g. fibers), while the hypotube may be of any suitable gauge,such as an 18 gauge hypotube. In some embodiments, the image guide maycontain about at least 1,000 elements, at least 3,000 elements, at least8,000 elements, at least 10,000 elements, at least 12,000 elements, atleast 15,000 elements, at least 20,000 elements, at least 30,000elements, or more than 30,000 elements. The elongated body may comprisean infusion lumen, such as an annular space between the optical hypotubeand the inside diameter of the outer tubular body. The lumen may beutilized for infusion of a therapeutic medium such as saline, liquidcontaining biological components such as stem cells, synthetic lubricantor other flowable media. In some embodiments, the lumen may be used todeliver saline to a tissue site or other therapeutic agents, such asgrowth factors, anti-bacterial molecules, or anti-inflammatorymolecules. In certain embodiments, and as described elsewhere in thespecification, the optical hypotube may be located non-concentricallywithin the elongated body. For example, the central axis of the opticalhypotube may be biased towards one side or another of the elongatedbody. The optical hypotube may be aligned along the bottom of theelongated body to aid in blunting of the sharpened distal tip of theelongated body. Further, in certain embodiments and as describedelsewhere in the specification, the distal end of the optical hypotubemay be bent to provide an enhanced field of view. A difference in axesbetween the optical hypotube and the elongated body would alsoadvantageously allow for more vertical clearance of the optical hypotubewhen the optical hypotube comprises a bent/deflected distal tip.

In some embodiments, the visualization devices described herein thissection or elsewhere in the specification may be used for various imageguided injections beyond joint injections. For example, drugs sometimesneed to be injected into the pericardium around the heart. Currently,such injections are completed blindly or with expensive visualization.As an alternative application, the visualization devices can be usedwhen pericardial effusion occurs, a condition that occurs when too muchfluid builds up around the heart. The physician can use a needle toenter the pericardial space and then drain fluid from the pericardiumvia a procedure known as pericardiocentesis. However, such a task couldalso be completed using certain embodiments of the tissue visualizationdevices, via penetration of the pericardium with the elongated body,followed by fluid drainage. Currently, physicians use imaging devicessuch as echocardiography or fluoroscopy (X ray) to guide this type ofwork.

The elongated body is carried by a proximal hand piece, which may beconnected via cable or wireless connection to a monitor such as an iPador other display. Output video and/or image data may be transmitted bythe cable or wireless connection. The proximal hand piece includes a CCDor CMOS optical sensor, for capturing still and/or video images. Theimaging device of the present invention enables accurate positioning ofthe distal end of the elongated body such as within a joint capsuleunder direct visualization. The imaging device provides a diagnosticfunction, allowing a clinician or others to effectively diagnose aninjury and/or condition. In embodiments, the device can also allow forreliable delivery of therapeutic media into a joint while in aphysician's office under local anesthetic, thereby avoiding the need forother diagnostic procedures that may be less accurate and/or require alonger wait period.

In some embodiments, a tissue visualization device comprises:

a handpiece comprising a visualization sensor configured to collect animage of an internal tissue site;

at least one lens;

an elongated body comprising a proximal end and a distal end, theelongated body comprising a lumen configured to deliver a fluid to atissue site and an optical hypotube;

an algorithm stored in the handpiece, the algorithm configured tocorrect optical aberrations in the image of the internal tissue site;

a distal end comprising a sharpened, deflected tip.

In certain embodiments, the optical correction may be generated bycomparing a captured image to a known definition pattern and generatingan algorithm that corrects chromatic aberrations and image distortionspecific to each individual tissue visualization device. In someembodiments, the optical correction may be unique to an individualtissue visualization device. In particular embodiments, additionalinformation regarding the tissue visualization device may be stored,such as the X,Y position of the center of the lens, the image circlesize, and unique characterisitic of the LED so as to provide aconsistent initial light level. The aforementioned characteristics ofthe tissue visualization device and additional characteristics describedelsewhere in the specification may be determined during manufacturingand stored in computer memory such as electrically erasable programmableread-only memory (EEPROM). In embodiments, the entirety of the handpieceand the elongated body may be an integrated unit. In certainembodiments, the handpiece further comprises a retraction control,configured to retract the elongated body so as to expose the distal lensof the optical hypotube. In some embodiments, the handpiece may furthercomprise a luer, configured to conduct fluid to the internal tissue sitevia the lumen.

In particular embodiments, a method of optical correction comprises:

focusing a tissue visualization device on a known definition pattern;

capturing an image of the known definition pattern;

comparing the image of the known definition pattern to a reference dataset corresponding to the known definition pattern;

generating an algorithm based on the differences between the image ofthe known definition pattern and the known definition pattern, thealgorithm configured to restore the image of the known definitionpattern to the parameters of the known definition pattern;

storing the optical correction within the tissue visualization device;and

utilizing the optical correction to correct images collected by thetissue visualization device.

In some embodiments, the method may further comprise inserting thetissue visualization device into a tissue site and collecting an image.In certain embodiments, a system for the visualization of a tissue sitemay comprise: a fully integrated tissue visualization device including ahand piece, image sensor in the hand piece and integrated probe withfiber optics and an infusion lumen; a displayer configured to displayimages collected by the tissue visualization device; and a cable theprovides for electrical communication between the displayer and thetissue visualization device.

In certain embodiments, a sterilized, integrated, one time usedisposable tissue visualization device, may comprise:

a handle comprising a visualization sensor;

a monitor configured to display an image;

an elongated body, extending along a longitudinal axis between aproximal end affixed to the handle, and a distal end comprising alaterally deflected, sharpened tip;

an elongate optical element extending through the elongated body, theoptical element having a proximal end in optical communication with thevisualization sensor and a distal end;

a control on the handle, for axially moving the elongated body between aproximal position in which the sharpened tip is proximal to the distalend of the optical element, and a distal position in which the sharpenedtip is distal to the distal end of the optical element;

wherein the distal end of the elongated body is configured to piercethrough tissue along the longitudinal axis; and

wherein the distal end of the elongate optical element comprises aviewing axis deflected laterally from the longitudinal axis.

In embodiments, the lateral displacement of the sharpened tip is 50% ofan outside diameter of the elongated body. The viewing axis may be at a15 degree angle from the longitudinal axis. The elongate optical elementmay further comprise a field of view, the field of view comprising afrontward view along the longitudinal axis. In embodiments, thevisualization sensor communicates with the monitor wirelessly. Thehandle may comprise a clamshell shape. The distal end may be laterallydeflected via an axially movable control wire. The elongated body maycomprise a lumen configured to deliver an anti-inflammatory agent to theinternal tissue site. In embodiments, a tissue visualization device mayfurther comprise a rotational sensor, the rotational sensor configuredto determine the rotational orientation of the visualization device. Therotational sensor may communicate with the monitor to rotate the imagesuch that a patient reference direction will always appear on the top ofthe screen. In embodiments, the elongated body may comprise an outertubular body, wherein the outer tubular body is constructed from aheat-sensitive material.

In certain embodiments, a method of manufacturing a tissue visualizationdevice may comprise:

slicing a tubular reflective material at a desired angle to expose anangled surface;

milling the angled surface until the angled surface is configured toreflect an image;

inserting the tubular reflective material into a tubular body, thetubular body comprising a gap; and

positioning the tubular reflective material such that the angled surfacereflects light passing through the gap.

In embodiments, an integrated, one time use disposable tissuevisualization device may comprise:

a handle;

an elongate rigid tubular probe, extending along a longitudinal axisbetween a proximal end affixed to the handle, and a distal end having asharpened tip;

an image sensor in the handle;

an elongate imaging fiber extending through the probe, the imaging fiberhaving a proximal end in optical communication with the sensor and adistal end;

a control on the handle, for axially moving the tubular probe between aproximal position in which the sharpened tip is proximal to the distalend of the optical element, and a distal position in which the sharpenedtip is distal to the distal end of the optical element;

a lens in optical communication with the distal end of the imagingfiber, and

a mask on the lens, the mask comprising an annular barrier for blockingvisible light, surrounding an optically transparent window forincreasing a depth of field perceived by the image sensor.

In embodiments, the distal end of the tubular probe is provided with alateral deflection. The handle may further comprise an image capturecontrol on the handle. The deflection may be in a first directionrelative to the longitudinal axis, and the cord may be attached to thehandle at a second direction relative to the longitudinal axis,approximately 180 degrees offset from the first direction. The axialproximal movement of the tubular probe may deflect the distal end of theoptical element laterally by at least about 1 degree. In certainembodiments, wherein the lens has an outside diameter of no more thanabout 0.75 mm and/or 1, no more than about 0.5 mm. In certainembodiments, the window has a diameter within the range of from about 50microns to about 300 microns. The window may have a diameter within therange of from about 100 microns to about 200 microns.

In embodiments, the lens may comprise a gradient-index optics lens witha flat distal surface. The tissue visualization device may furthercomprise a plurality of axially extending illumination fibers spacedcircumferentially apart around the lens. In some embodiments, the themask comprises a thin film coating. The mask may comprises a lowreflectance chrome coating.e visualization device of claim 1, comprisingan annular lumen extending the length of the tubular probe, andpositioned in between the imaging fiber and an inside surface of theelongate probe. In certain embodiments, the lumen is in communicationwith an injection or aspiration port on the handle. The mask may have atransmission of light in the visible range of no more than about 10%.The mask may further have a transmission of light in the visible rangeof no more than about 5%.

In particular embodiments, a distal end assembly for an elongate viewinginstrument, comprises:

an imaging fiber bundle, having a fiber bundle distal end;

a lens, optically coupled to the distal end of the fiber bundle, thelens having a lens distal end;

a non-powered plate, optically coupled to the lens distal end; and

a mask in between the lens and the plate, the mask comprising an annularbarrier for blocking visible light, surrounding an optically transparentwindow through the plate for increasing a depth of field perceived bythe viewing instrument.

In certain embodiments, the mask is carried by the plate. The mask maycomprise a coating applied to the plate. The lens may have an outsidediameter of no more than about 0.75 mm or no more than about 0.5 mm. Incertain embodiments, the window has a diameter within the range of fromabout 50 microns to about 300 microns. The window may have a diameterwithin the range of from about 100 microns to about 200 microns. Incertain embodiments, the lens comprises a gradient-index optics lenswith a flat distal surface. The distal end of the assembly may furthercomprise a plurality of axially extending illumination fibers spacedcircumferentially apart around the lens.

In certain embodiments, a tissue visualization device, comprises:

a handle;

an elongate tubular probe, extending along a longitudinal axis between aproximal end affixed to the handle, and a distal end having a sharpenedtip;

an image sensor in the handle;

an elongate imaging fiber extending through the probe, the imaging fiberhaving a proximal end in optical communication with the sensor and adistal end;

a lens in optical communication with the distal end of the imagingfiber, and

a mask in optical communication with the lens, the mask comprising anannular barrier for blocking visible light, surrounding an opticallytransparent window for increasing a depth of field perceived by theimage sensor;

wherein the mask resides in a plane which is spaced apart along anoptical path from a focus point for the lens.

The tissue visualization device may further comprise a non-poweredoptically transmissive plate, and the mask is positioned in between thelens and the plate. The mask may comprises a coating on the plate. Thecoating may comprise a low transmission and low reflection in thevisible range. In certain embodiments, a diameter of the active area ofthe imaging fiber is at least two times a diameter of the window.

In embodiments, a depth of field enhanced optical assembly for thedistal end of an imaging probe may comprise:

a powered lens, having a distal end and an optical path extendingtherethrough;

a nonpowered plate in the optical path and adjacent the lens distal end;and

a mask in between the lens and the plate, the mask comprising an annularbarrier for blocking visible light, surrounding an optically transparentwindow aligned with the optical path.

In embodiments, the lens may comprise a graded index lens. The mask maycomprise a low reflective coating on the plate. In certain embodiments,the coating comprises chrome.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present invention will be apparentfrom the following detailed description of the invention, taken inconjunction with the accompanying drawings of which:

FIG. 1 illustrates an embodiment of a tissue visualization system.

FIGS. 2A-C illustrate various embodiments of a tissue visualizationdevice.

FIGS. 3A-C illustrate close-up cross-sectional side views of embodimentsof the distal end of the tissue visualization device illustrated in FIG.2A.

FIG. 4 illustrates a cross-sectional top view of an embodiment of atissue visualization and modification device

FIG. 5 illustrates a cross-sectional view of an embodiment of a tubularportion of a tissue visualization and modification device.

FIGS. 6A-C illustrate embodiments of a tissue visualization device withthe outer housing removed.

FIG. 7 illustrates a cross-sectional side view of an embodiment of thelens housing depicted in FIG. 6A-C.

FIGS. 8A-B illustrates embodiments of images with or without rotationalimage stabilization.

FIGS. 9A-D illustrate embodiments of a tissue visualization devicecomprising a mirrored surface.

FIGS. 10A-C illustrate embodiments of a tissue visualization device.

FIG. 11 is a comparison of pictures taken with and without embodimentsof a non-powered plate and mask.

FIG. 12 is a close up view of an embodiment of a non-powered plate withan optical mask.

FIGS. 13A-C depict embodiments of a tissue visualization devicecomprising bent optical hypotubes.

FIGS. 14A-B are a photograph and illustration of embodiments of thedistal tip of a tissue visualization device.

FIG. 15 depicts embodiments of a method for visualization an internaltissue site.

FIG. 16 depicts an embodiments of a visualization sensor at the distalend of a tissue visualization device.

FIG. 17 depicts an embodiment of a tissue visualization device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments disclosed in this section or elsewhere in this applicationrelate to minimally invasive tissue visualization and access systems anddevices. Also provided are methods of using the systems in imagingapplications, as well as kits for performing the methods. Before thepresent invention is described in greater detail, it is to be understoodthat this invention is not limited to particular embodiments described,as such may, of course, vary. It is also to be understood that theterminology used herein is for the purpose of describing particularembodiments only, and is not intended to be limiting, since the scope ofthe present invention will be limited only by the appended claims. Wherea range of values is provided, it is understood that each interveningvalue between the upper and lower limit of that range and any otherstated or intervening value in that stated range, is encompassed withinthe invention. The upper and lower limits of these smaller ranges mayindependently be included in the smaller ranges and are also encompassedwithin the invention, subject to any specifically excluded limit in thestated range. Where the stated range includes one or both of the limits,ranges excluding either or both of those included limits are alsoincluded in the invention.

Certain ranges are presented herein with numerical values being precededby the terms “about,” “around,” and “approximately.” These terms areused herein to provide literal support for the exact number that itprecedes, as well as a number that is near to or approximately thenumber that the term precedes. In determining whether a number is nearto or approximately a specifically recited number, the near orapproximating unrecited number may be a number which, in the context inwhich it is presented, provides the substantial equivalent of thespecifically recited number.

All publications and patents cited in this specification are hereinincorporated by reference as if each individual publication or patentwere specifically and individually indicated to be incorporated byreference and are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited. The citation of any publication is for itsdisclosure prior to the filing date and should not be construed as anadmission that the present invention is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dateswhich may need to be independently confirmed.

It is noted that, as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. It is further noted that the claimsmay be drafted to exclude any optional element. As such, this statementis intended to serve as antecedent basis for use of such exclusiveterminology as “solely,” “only” and the like in connection with therecitation of claim elements, or use of a “negative” limitation.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinvention. Any recited method can be carried out in the order of eventsrecited or in any other order which is logically possible.

As summarized above, aspects of the invention include minimally invasiveimaging and visualization systems. In some embodiments, imaging systemsof the invention are minimally invasive, such that they may beintroduced to an internal target site of a patient, for example, aspinal location that is near or inside of an intervertebral disc or anorthopedic joint capsule, through a minimal incision.

In some embodiments, imaging systems of the invention may include bothan access device and an elongated body. The access device may be atubular device having a proximal end and a distal end and an internalpassageway extending from the proximal to distal end. Similarly, theelongated body has a proximal end and a distal end and is dimensioned tobe slidably moved through the internal passageway of the access device.

In particular embodiments, access devices of the invention are elongatedelements having an internal passageway that are configured to provideaccess to a user (e.g., a health care professional, such as a surgeon)from an extra-corporeal location to an internal target tissue site,e.g., a location near or in the spine or component thereof, e.g., nearor in an intervertebral disc, inside of the disc, etc., through aminimally invasive incision. Access devices of the invention may becannulas, components of retractor tube systems, etc. As the accessdevices are elongate, they have a length that is 1.5 times or longerthan their width, such as 2 times or longer than their width, including5 or even 10 times or longer than their width, e.g., 20 times longerthan its width, 30 times longer than its width, or longer.

In certain embodiments, where the access devices are configured toprovide access through a minimally invasive incision, the longestcross-sectional outer dimension of the access devices may (for example,the outer diameter of a tube shaped access device, including wallthickness of the access device, which may be a port or cannula in someinstances) range in certain instances from 5 mm to 50 mm, such as 10 to20 mm. With respect to the internal passageway, this passage can bedimensioned to provide passage of the imaging devices from anextra-corporeal site to the internal target tissue location. In certainembodiments, the longest cross-sectional dimension of the internalpassageway, e.g., the inner diameter of a tubular shaped access device,ranges in length from 5 to 30 mm, such as 5 to 25 mm, including 5 to 20mm, e.g., 7 to 18 mm. Where desired, the access devices are sufficientlyrigid to maintain mechanical separation of tissue, e.g., muscle, and maybe fabricated from any convenient material. Materials of interest fromwhich the access devices may be fabricated include, but are not limitedto: metals, such as stainless steel and other medical grade metallicmaterials, plastics, and the like.

The systems of the invention may further include an elongated bodyhaving a proximal and distal end, where the elongated body isdimensioned to be slidably moved through the internal passageway of theaccess device or directly through tissue without the use of anadditional access device. As this component of the system is elongate,it has a length that is 1.5 times or longer than its width, such as 2times or longer than its width, including 5 or even 10 times or longerthan its width, e.g., 20 times longer than its width, 30 times longerthan its width, or longer. When designed for use in knee jointprocedures, the elongated body is dimensioned to access the capsule ofthe knee joint. At least the distal end of the device has a longestcross-sectional dimension that is 10 mm or less, such as 8 mm or lessand including 7 mm or less, where in certain embodiments the longestcross-sectional dimension has a length ranging from 5 to 10 mm, such as6 to 9 mm, and including 6 to 8 mm. The elongated body may be solid orinclude one or more lumens, such that it may be viewed as a catheter.The term “catheter” is employed in its conventional sense to refer to ahollow, flexible or semi-rigid tube configured to be inserted into abody. Catheters of the invention may include a single lumen, or two ormore lumens, e.g., three or more lumens, etc, as desired. Depending onthe particular embodiment, the elongated bodies may be flexible orrigid, and may be fabricated from any convenient material.

As summarized above, some embodiments of the invention includevisualization sensors and illumination elements. In certain embodimentsthese visualization sensors are positioned within a handle at theproximal end of the device. The system may include one or morevisualization sensors at the proximal end of the device and one or moreillumination elements that are located among the distal and/or proximalends of the elongated body. In particular embodiments, one or morevisualization sensors, such as those described in this section orelsewhere in the specification, may be located in the distal end of thedevice such as within the distal end of the elongated body. In someembodiments, one or more visualization sensors may be located at variouslocations within the elongated body, such as at approximatelyone-quarter the length of the elongated body from the distal end,one-half, or three quarters the length of the elongated body from thedistal end. In certain embodiments, the visualization sensors may beminiaturized such that they do not substantially increase the outerdiameter of the elongated body.

Similarly, with respect to the illumination elements, embodiments of thesystems include those systems where one or more illumination elementsare located at the distal and/or proximal end of the elongated body.Embodiments of the systems also include those systems where oneillumination element is located at the distal and/or proximal end of theelongated body and another illumination element is located at the distaland/or proximal end of the access device. Furthermore, embodiments ofthe systems include those systems where one or more illuminationelements are located at the proximal end of the device and light ispropagated via wave guides such as a fiber optic bundle towards thedistal end of the device. A longest cross section dimension for theelongated body is generally 20 mm or less, 10 mm or less, 6 mm or less,such as 5 mm or less, including 4 mm or less, and even 3 mm or less.

The elongated body preferably contains an image capture waveguide, anillumination waveguide and a lumen for fluid irrigation or aspiration.

In certain embodiments, miniature visualization sensors have a longestcross-section dimension (such as a diagonal dimension) of 20 mm or less,10 mm or less, 5 mm or less, or 3 mm or less, where in certain instancesthe sensors may have a longest cross-sectional dimension ranging from 2to 3 mm. In certain embodiments, the miniature visualization sensorshave a cross-sectional area that is sufficiently small for its intendeduse and yet retain a sufficiently high matrix resolution. In certainembodiments, miniature visualization sensors may have a longest-crosssectional dimension of 0.5 mm. In some embodiments, the longestcross-sectional dimension is approximately 0.1 mm, 0.2 mm, 0.3 mm, 0.4mm, or greater than 0.5 mm. In certain embodiments, the visualizationsensors may be between 1-2 mm, such as 1.3 mm, or between 0.5-1 mm, suchas 0.75 mm. Examples of smaller sized visualization sensors are producedby Fujikura and Medigus. Certain visualization sensors of the may have across-sectional area (i.e. an x-y dimension, also known as packaged chipsize) that is 2 mm×2 mm or less, such as 1.8 mm×1.8 mm or less, and yethave a matrix resolution of 400×400 or greater, such as 640×480 orgreater. In some instances, the visualization sensors have a sensitivitythat is 500 mV/Lux-sec or greater, such as 700 mV/Lux-Sec or greater,including 1000 mV/Lux-Sec or greater, where in some instances thesensitivity of the sensor is 2000 mV/Lux-Sec or greater, such as 3000mV/Lux-Sec or greater. In particular embodiments, the visualizationsensors of interest are those that include a photosensitive component,e.g., array of photosensitive elements, coupled to an integratedcircuit, where the integrated circuit is configured to obtain andintegrate the signals from the photosensitive array and output theanalog data to a backend processor. The visualization sensors ofinterest may be viewed as integrated circuit image sensors, and includecomplementary metal-oxide-semiconductor (CMOS) sensors andcharge-coupled device (CCD) sensors. In certain embodiments, thevisualization sensors may further include a lens positioned relative tothe photosensitive component so as to focus images on the photosensitivecomponent.

Visualization sensors of interest include, but are not limited to, thoseobtainable from: OminVision Technologies Inc., Sony Corporation, CypressSemiconductors. The visualization sensors may be integrated with thecomponent of interest, e.g., the proximal handle or the elongatedstructure or both. In some embodiments, as the visualization sensor(s)is integrated at the proximal end of the component, it cannot be removedfrom the remainder of the component without significantly compromisingthe structure of component. As such, the integrated visualization sensormay not be readily removable from the remainder of the component, suchthat the visualization sensor and remainder of the component form aninter-related whole. As described above, in some embodiments, thevisualization sensor(s) may be located at the distal end of theelongated body or elsewhere along the elongated body.

While any convenient visualization sensor may be employed in devices ofthe invention, in certain instances the visualization sensor may be aCMOS sensor. For example, the CMOS sensor may be an Aptina CMOS sensorsuch as the APtina MT9V124. Such a CMOS sensor may provide very smallpixels, with small package sizes coupled with low-voltage differentialsignaling (LVDS). Such a CMOS sensor allows the cable to the display tocomprise less conductors, and thus may allow for reduced cable costs ascompared to other options. Of additional interest as CMOS sensors arethe OmniPixel line of CMOS sensors available from OmniVision (Sunnyvale,Calif.), including the OmniPixel, OmniPixel2, OmniPixel3, OmniPixel3-HSand OmniBSI lines of CMOS sensors. These sensors may be either frontsideor backside illumination sensors. Aspects of these sensors are furtherdescribed in one or more the following U.S. patents, the disclosures ofwhich are herein incorporated by reference: U.S. Pat. Nos. 7,388,242;7,368,772; 7,355,228; 7,345,330; 7,344,910; 7,268,335; 7,209,601;7,196,314; 7,193,198; 7,161,130; and 7,154,137.

In certain embodiments, the elongated body may further include one ormore infusion lumens that run at least the substantial length of thedevice, e.g., for performing a variety of different functions. Incertain embodiments where it is desired to flush (i.e., wash) thelocation of the target tissue at the distal end of the elongated bodyand remove excess fluid, the elongated body may include both anirrigation and aspiration lumen. During use, the irrigation lumen isoperatively connected to a fluid source (e.g., physiologicallyacceptable fluid, such as saline) at the proximal end of the device,where the fluid source is configured to introduce fluid into the lumenunder positive pressure, e.g., at a pressure ranging from 0 to 500 mmHg, so that fluid is conveyed along the irrigation lumen and out thedistal end.

While the dimensions of the irrigating lumen may vary, in certainembodiments the longest cross-sectional dimension of the irrigationlumen ranges from 1 to 3 mm. During use, the aspiration lumen isoperatively connected to a source of negative pressure (e.g., vacuumsource) at the proximal end of the device, where the negative pressuresource is configured to draw fluid from the tissue location at thedistal end into the irrigation lumen under positive pressure, e.g., at apressure ranging from 50 to 600 mm Hg, so that fluid is removed from thetissue site and conveyed along the irrigation lumen and out the proximalend, e.g., into a waste reservoir. While the dimensions of theaspiration lumen may vary, in certain embodiments the longestcross-sectional dimension of the aspiration lumen ranges from about 1 to10 mm, about 1 to 4 mm, about 1 to 3 mm, or less than 1 mm.Alternatively, a single lumen may be provided, through which irrigationand/or aspiration may be accomplished. In embodiments, the productpackaging may include a single port stopcock as a means to control fluidflow. In particular embodiments, the stopcock or suitable valve may bedirectly integrated into the device. In further embodiments, more thanone port or stopcock may be used, such as two ports and two stopcocks,three ports and three stopcocks, and so on. In some embodiments, a threeway stopcock may be provided so a clinician can ‘toggle’ betweeninfusion and aspiration, or infusion of a first and second fluid,without connecting and reconnecting tubes.

In certain embodiments, the systems of the invention are used inconjunction with a controller configured to control illumination of theillumination elements and/or capture of images (e.g., as still images orvideo output) from the visualization sensors. This controller may take avariety of different formats, including hardware, software andcombinations thereof. The controller may be physically located relativeto the elongated body and/or access device at any convenient locationsuch as at the proximal end of the system. In certain embodiments, thecontroller may be distinct from the system components, i.e., elongatedbody, such that a controller interface is provided that is distinct fromthe proximal handle, or the controller may be integral with the proximalhandle.

FIG. 1 illustrates an embodiment of a system 2 for the visualization ofan interior tissue site. In some embodiments, a tissue visualizationsystem 2 comprises: a tissue visualization device 4, described in muchgreater detail below, a controller 6, and a cable 8 that provideselectrical communication between the controller 6 and the tissuevisualization device 4.

In certain embodiments, the controller 6 may comprise a housing having amemory port such as an SD card slot 10 and a camera button 12. Thecamera button 12 may activate the system to collect and store a still ormoving image. The controller 6 may further comprise a power button 14, amode switch button 16, and brightness controls 18. The controller 6 canfurther comprise a display such as a screen 19 for displaying stillimages and/or video.

Activating the mode switch button 10 may switch the system betweendifferent modes such as a procedure mode in which video and/or stillimages are collected and displayed in real-time on the video screen 19and a consultation mode, in which a clinician may selectively displaystored images and video on the video screen 19 for analysis. Forexample, while in procedure mode, the system could display video orimages from the visualization sensor in real-time. By real-time, it ismeant that the screen 19 can show video of the interior of a tissue siteas it is being explored by the clinician. The video and/or images canfurther be stored automatically by the system for replay at a latertime. For another example, while in consult mode, the screen 19 mayconveniently display specific images or videos that have previously beenacquired by the system, so that the clinician can easily analyze thecollected images/data, and discuss the images and data with a patient.In some embodiments, the clinician may be able to annotate the imagesvia a touch screen or other suitable means.

In certain embodiments, the screen 19 may be any type of image planesuitable for visualizing an image, such as the screen on an iPad, acamera, a computer monitor, cellular telephone or a display carried by ahead worn support such as eyeglasses or other heads up display. Incertain embodiments, the cable may be avoided by configuring the deviceand display to communicate wirelessly.

In some embodiments, it may be desirable to remove the cord and provideinstead a wireless communication link between the probe and the monitorand possibly also to a centralized medical records storage and/orevaluation location. Local transmission such as to the monitor within amedical suite may be accomplished via a local area network such as, forexample, a “WiFi” network based on IEEE 802.11 wireless local areanetworking standards, Bluetooth wireless personal area networkingstandard, or the low power consumption ANT wireless protocol.Transceiver chips and associated circuitry are well understood in theart, and may be located within the hand piece housing of thevisualization device 4, which is discussed below.

As a further alternative to conventional WiFi or IEEE 801.11-based localarea networks, ZIGBEE networks based on the IEEE 802.15.4 standard forwireless personal area networks have been used for collectinginformation from a variety of medical devices in accordance with IEEE11073 Device Specializations for point-of-care medical devicecommunication, including for example pulse oximeters, blood pressuremonitors, pulse monitors, weight scales and glucose meters. As comparedto present IEEE 802.15.1 BLUETOOTH wireless personal area networks, forexample, ZIGBEE networks provide the advantage of operating with lowpower requirements (enabling, for example, ZIGBEE transceivers to beintegrally coupled to the probe under battery power). However,transmission ranges between individual ZIGBEE transceivers are generallylimited to no more than several hundred feet. As a consequence, suchnetworks are suitable for on-site communications with medical devices,but unusable for centralized monitoring locations located off-site.Therefore, a hybrid system may be desirable in which one or morewireless personal area networks are configured to facilitate on-sitecommunications between the probe and associated monitor, and alsobetween the probe and one or more wireless relay modules which arefurther configured to communicate with off-site centralized monitoringsystems (for example, via internet connection or a wireless wide-areanetwork (WWAN) such as a mobile telephone data network, for example,based on a Global System for Mobile Communications (GSM) or CodeDivision Multiple Access (CDMA) cellular network or associated wirelessdata channels). Suitable relay modules and systems are respectivelydescribed in patent applications entitled “Wireless Relay Module forRemote Monitoring Systems” (U.S. application Ser. No. 13/006,769, filedJan. 14, 2011) and “Medical Device Wireless Network Architectures” (U.S.application Ser. No. 13/006,784, filed Jan. 14, 2011) which are herebyincorporated by reference within this patent application.

Thus any of the probes disclosed herein may be provided with aninterface circuit that includes a transceiver having one or more of atransmitter and/or a receiver for respectively transmitting andreceiving video image, still image and potentially other signals withthe associated monitor within the medical suite over a wireless networksuch as, for example, a Low-Rate Wireless Personal Area Networks or“LR-WPAN,” ZIGBEE network or another low-power personal area networksuch as a low power BLUETOOTH or other WiFi network, existing orsubsequently developed.

Optionally also provided within the patient facility are one or morerelay modules. Each relay module includes a first transceiver forreceiving signals from and transmitting signals to the interface circuitwithin a hand probe or the associated monitor, and further includes anoutput such as an internet connection or a second transceiver forwirelessly transmitting signals to and receiving signals from an accesspoint via a wireless wide-area network (“WWAN”). Suitable WWANs for usewith the present invention include, for example, networks based on aGlobal System for Mobile Communications (GSM) or Code Division MultipleAccess (CDMA) cellular network or associated with the 2G, 3G, 3G LongTerm Evolution, 4G, WiMAX cellular wireless standards of theInternational Telecommunication Union Radiocommunication Sector (ITU-R).For compliance with any applicable patient data privacy provisions ofthe Health Insurance Portability and Accountability Act of 1996 (HIPAA),communications over each of the facility-oriented wireless network andWWAN are preferably conducted securely using, for example, using aSecure Sockets Layer (SSL) protocol or a Transport Layer Security (TLS)protocol.

Also provided are kits for use in practicing the subject methods, wherethe kits may include one or more of the above devices, and/or componentsof the subject systems, as described above. As such, a kit may include avisualization device and a cable for connection to a controller,contained within a sterile package. The kit may further include othercomponents, e.g., a controller, guidewires, stylets, etc., which mayfind use in practicing the subject methods. Various components may bepackaged as desired, e.g., together or separately. Preferably, thecomponents within the package are pre-sterilized. Further detailsregarding pre-sterilization of packaging may be found in U.S. Pat. No.8,584,853, filed Feb. 16, 2013, and hereby incorporated by referenceinto this specification.

In addition to above mentioned components, the subject kits may furtherinclude instructions for using the components of the kit to practice thesubject methods. The instructions for practicing the subject methods maybe recorded on a suitable recording medium. For example, theinstructions may be printed on a substrate, such as paper or plastic,etc. As such, the instructions may be present in the kits as a packageinsert, in the labeling of the container of the kit or componentsthereof (i.e., associated with the packaging or subpackaging) etc. Inother embodiments, the instructions are present as an electronic storagedata file present on a suitable computer readable storage medium, e.g.CD-ROM, diskette, etc. In yet other embodiments, the actual instructionsare not present in the kit, but means for obtaining the instructionsfrom a remote source, e.g. via the internet, are provided. An example ofthis embodiment is a kit that includes a web address where theinstructions can be viewed and/or from which the instructions can bedownloaded. As with the instructions, this means for obtaining theinstructions is recorded on a suitable substrate.

Also of interest is programming that is configured for operating avisualization device according to methods of invention, where theprogramming is recorded on physical computer readable media, e.g. anymedium that can be read and accessed directly by a computer. Such mediainclude, but are not limited to: magnetic storage media, such as floppydiscs, hard disc storage medium, and magnetic tape; optical storagemedia such as CD-ROM; electrical storage media such as RAM and ROM; andhybrids of these categories such as magnetic/optical storage media. Oneof skill in the art can readily appreciate how any of the presentlyknown computer readable mediums can be used to create a manufacturecomprising a storage medium having instructions for operating aminimally invasive in accordance with the invention.

In some embodiments, programming of the device includes instructions foroperating a device of the invention, such that upon execution by theprogramming, the executed instructions result in execution of theimaging device to: illuminate a target tissue site, such as anorthopedic joint or portion thereof; and capture one or more imageframes of the illuminated target tissue site with the visualizationsensor.

Visualization sensors of interest are those that include aphotosensitive component, e.g., array of photosensitive elements thatconvert light into electrons, coupled to an integrated circuit. Theintegrated circuit may be configured to obtain and integrate the signalsfrom the photosensitive array and output image data, which image datamay in turn be conveyed to an extra-corporeal display configured toreceive the data and display it to a user. The visualization sensors ofthese embodiments may be viewed as integrated circuit image sensors.

The integrated circuit component of these sensors may include a varietyof different types of functionalities, including but not limited to:image signal processing, memory, and data transmission circuitry totransmit data from the visualization sensor to an extra-corporeallocation, etc. The miniature visualization sensors may further include alens component made up of one or more lenses positioned relative to thephotosensitive component so as to focus images on the photosensitivecomponent. Where desired, the one or more lenses may be present in ahousing. Specific types of miniature visualization sensors of interestinclude complementary metal-oxide-semiconductor (CMOS) sensors andcharge-coupled device (CCD) sensors. The sensors may have any convenientconfiguration, including circular, square, rectangular, etc.Visualization sensors of interest may have a longest cross-sectionaldimension that varies depending on the particular embodiment, where insome instances the longest cross sectional dimension (e.g., diameter) is10.0 mm or less, such as 6.0 mm or less, including 3.0 mm or less.

Visualization sensors of interest may be either frontside or backsideillumination sensors, and have sufficiently small dimensions whilemaintaining sufficient functionality to be integrated at the proximalend of the elongated bodies within the hand piece of the devices of theinvention. Aspects of these sensors are further described in one or morethe following U.S. patents, the disclosures of which are hereinincorporated by reference: U.S. Pat. Nos. 7,388,242; 7,368,772;7,355,228; 7,345,330; 7,344,910; 7,268,335; 7,209,601; 7,196,314;7,193,198; 7,161,130; and 7,154,137.

The distal end of the elongated body may be configured for front viewingand/or side-viewing, as desired. In yet other embodiments, the elongatedbody may be configured to provide image data from both the front and theside, e.g., where the primary viewing axis from the distal end of thewaveguide extends at an angle that is greater than about 2° or 5° or 10°or 15° or more relative to the longitudinal axis of the elongated body,described in greater detail below.

Depending on the particular device embodiment, the elongated body may ormay not include one or more lumens that extend at least partially alongits length. When present, the lumens may vary in diameter and may beemployed for a variety of different purposes, such as irrigation,aspiration, electrical isolation (for example of conductive members,such as wires), as a mechanical guide, etc., as reviewed in greaterdetail below. When present, such lumens may have a longest cross sectionthat varies, ranging in some in stances from 0.5 to 5.0 mm, such as 1.0to 4.5 mm, including 1.0 to 4.0 mm. The lumens may have any convenientcross-sectional shape, including but not limited to circular, square,rectangular, triangular, semi-circular, trapezoidal, irregular, etc., asdesired. These lumens may be provided for a variety of differentfunctions, including as irrigation and/or aspiration lumens, asdescribed in greater detail below.

In certain embodiments, the devices may include one or more illuminationelements configured to illuminate a target tissue location so that thelocation can be visualized with a visualization sensor, e.g., asdescribed above. A variety of different types of light sources may beemployed as illumination elements, so long as their dimensions are suchthat they can be positioned at or carry light to the distal end of theelongated body. The light sources may be integrated with a givencomponent (e.g., elongated body) such that they are configured relativeto the component such that the light source element cannot be removedfrom the remainder of the component without significantly compromisingthe structure of the component. As such, the integrated illuminationelement of these embodiments is not readily removable from the remainderof the component, such that the illumination element and remainder ofthe component form an inter-related whole. The light sources may belight emitting diodes configured to emit light of the desired wavelengthrange, or optical conveyance elements, e.g., optical fibers, configuredto convey light of the desired wavelength range from a location otherthan the distal end of the elongated body, e.g., a location at theproximal end of the elongated body within the hand piece, to the distalend of the elongated body.

As with the visualization sensors, the light sources may include aconductive element, e.g., wire, or an optical fiber or bundle, whichruns the length of the elongated body to provide for power and controlof the light sources from a location outside the body, e.g., anextracorporeal control device.

Where desired, the light sources may include a diffusion element toprovide for uniform illumination of the target tissue site. Anyconvenient diffusion element may be employed, including but not limitedto a translucent cover or layer (fabricated from any convenienttranslucent material) through which light from the light source passesand is thus diffused. In those embodiments of the invention where thesystem includes two or more illumination elements, the illuminationelements may emit light of the same wavelength or they may be spectrallydistinct light sources, where by “spectrally distinct” is meant that thelight sources emit light at wavelengths that do not substantiallyoverlap, such as white light and infra-red light. In certainembodiments, an illumination configuration as described in U.S.application Ser. Nos. 12/269,770 and 12/269,772 (the disclosures ofwhich are herein incorporated by reference) is present in the device.

In some embodiments, devices of the invention may include a linearmechanical actuator for linearly translating a distal end element of thedevice, such as a tubular needle which surrounds a visualization elementrelative to the visualization element. By “linearly translating” ismeant moving the along a substantially straight path. As used herein,the term “linear” also encompasses movement in a non-straight (i.e.,curved) path.

In some embodiments, an integrated articulation mechanism that impartssteerability to the distal end of the elongated body and/or distal endof the visualization element is also present in the device. By“steerability” is meant the ability to maneuver or orient thevisualization element, tissue modifier and/or distal end of theelongated body as desired during a procedure, e.g., by using controlspositioned at the proximal end of the device. In these embodiments, thedevices include a steerability mechanism (or one or more elementslocated at the distal end of the elongated body) which renders thedesired distal end component maneuverable as desired through proximalend control. As such, the term “steerability”, as used herein, refers toa mechanism that provides a user steering functionality, such as theability to change direction in a desired manner, such as by deflectingthe primary viewing axis left, right, up or down relative to the initialaxial direction.

The steering functionality can be provided by a variety of differentmechanisms. Examples of suitable mechanisms include, but are not limitedto one or more axially moveable pull or push wires, tubes, plates,meshes or combinations thereof, made from appropriate materials, such asshape memory materials, music wire, etc. For example, one activedeflection mechanism includes providing a plurality of transverse slotsspaced apart axially along a first side of the outer tubular body 1126within the distal segment 1108. A second side of the outer tubular body1126 within the distal segment 1108, opposite from (i.e., 180° from) thefirst side acts as an axially non-compressible spine, while the firstside may be compressed axially causing a lateral deflection concave inthe direction of the first side. Axial compression (or elongation) ofthe first side relative to the second side, to induce or removecurvature, may be accomplished by an axially movable control wire. Thedistal end of the control wire may be secured to the outer tubular body1126 within the distal segment 1108, preferably at the distal end of thedistal segment 1108. The control wire extends proximally throughout thelength of the outer tubular body 1126, to a proximal deflection control.Manipulation of the control to retract the control wire proximally willcollapse the transverse slots, shortening the axial length of the firstside relative to the second side, thereby deflecting the distal segment1108.

In some instances, the distal end of the elongated body is provided witha distinct, additional capability that allows it to be independentlyrotated about its longitudinal axis when a significant portion of theoperating handle is maintained in a fixed position, as discussed ingreater detail below.

The extent of distal primary viewing axis articulations of the inventionmay vary, such as from at least about 5°, 10°, 25°, or 35° or more fromthe primary viewing axis. The visualization element may be configuredfor rotating about its axis so that the full range of angles isaccessible on either side of the axis of the probe, essentiallymultiplying the effective viewing angle e.g., as described in greaterdetail below. Articulation mechanisms of interest are further describedin published PCT Application Publication Nos. WO 2009029639; WO2008/094444; WO 2008/094439 and WO 2008/094436; the disclosures of whichare herein incorporated by reference. Specific articulationconfigurations of interest are further described in connection with thefigures, below.

In certain embodiments, devices of the invention may further include anirrigator and aspirator configured to flush an internal target tissuesite and/or a component of the device, such as a lens of thevisualization sensor. As such, the elongated body may further includeone or more lumens that run at least the substantial length of thedevice, e.g., for performing a variety of different functions, assummarized above. In certain embodiments where it is desired to flush(i.e., wash) the target tissue site at the distal end of the elongatedbody (e.g. to remove ablated tissue from the location, etc.), theelongated body may include both irrigation lumens and aspiration lumens.Thus, the tissue modification device can comprise an irrigation lumenextending axially through the elongated body. During use, the irrigationlumen may be operatively connected to a fluid source (e.g., aphysiologically acceptable fluid, such as saline) at the proximal end ofthe device, where the fluid source is configured to introduce fluid intothe lumen under positive pressure, e.g., at a pressure ranging from 0psi to 60 psi, so that fluid is conveyed along the irrigation lumen andout the distal end. While the dimensions of the irrigation lumen mayvary, in certain embodiments the longest cross-sectional dimension ofthe irrigation lumen ranges from 0.5 mm to 5 mm, such as 0.5 mm to 3 mm,including 0.5 mm to 1.5 mm.

During use, the aspiration lumen may be operatively connected to asource of negative pressure (e.g., a vacuum source) at the proximal endof the device. While the dimensions of the aspiration lumen may vary, incertain embodiments the longest cross-sectional dimension of theaspiration lumen ranges from 1 mm to 7 mm, such as 1 mm to 6 mm,including 1 mm to 5 mm. In some embodiments, the aspirator comprises aport having a cross-sectional area that is 33% or more, such as 50% ormore, including 66% or more, of the cross-sectional area of the distalend of the elongated body.

In some instances, the negative pressure source is configured to drawfluid and/or tissue from the target tissue site at the distal end intothe aspiration lumen under negative pressure, e.g., at a negativepressure ranging from 300 to 600 mmHg, such as 550 mmHg, so that fluidand/or tissue is removed from the tissue site and conveyed along theaspiration lumen and out the proximal end, e.g., into a waste reservoir.In certain embodiments, the irrigation lumen and aspiration lumen may beseparate lumens, while in other embodiments, the irrigation lumen andthe aspiration functions can be accomplished in a single lumen.

In certain embodiments, the devices may include a control structure,such as a handle, operably connected to the proximal end of theelongated body. By “operably connected” is meant that one structure isin communication (for example, mechanical, electrical, opticalconnection, or the like) with another structure. When present, thecontrol structure (e.g., handle) is located at the proximal end of thedevice. The handle may have any convenient configuration, such as ahand-held wand with one or more control buttons, as a hand-held gun witha trigger, etc., where examples of suitable handle configurations arefurther provided below.

In some embodiments, the distal end of the elongated body is rotatableabout its longitudinal axis when a significant portion of the operatinghandle is maintained in a fixed position. As such, at least the distalend of the elongated body can turn by some degree while the handleattached to the proximal end of the elongated body stays in a fixedposition. The degree of rotation in a given device may vary, and mayrange from 0 to 360°, such as 0 to 270°, including 0 to 180°.

As described herein this section and elsewhere in the specification, incertain embodiments, the device may be disposable or reusable. As such,devices of the invention may be entirely reusable (e.g., be multi-usedevices) or be entirely disposable (e.g., where all components of thedevice are single-use). In some instances, the device can be entirelyreposable (e.g., where all components can be reused a limited number oftimes). Each of the components of the device may individually besingle-use, of limited reusability, or indefinitely reusable, resultingin an overall device or system comprised of components having differingusability parameters.

As described herein this section and elsewhere in the specification, incertain embodiments, devices of the invention may be fabricated usingany convenient materials or combination thereof, including but notlimited to: metallic materials such as tungsten, stainless steel alloys,platinum or its alloys, titanium or its alloys, molybdenum or itsalloys, and nickel or its alloys, etc.; polymeric materials, such aspolytetrafluoroethylene, polyimide, PEEK, and the like; ceramics, suchas alumina (e.g., STEATITE™ alumina, MAECOR™ alumina), etc. In someembodiments, materials that provide both structural as well as lightpiping properties may be used.

With respect to imaging the interior of a joint capsule, methods includepositioning a distal end of the visualization element of the inventionin viewing relationship to the target tissue. By viewing relationship ismeant that the distal end is positioned within 40 mm, such as within 10mm, including within 5 mm of the target tissue site of interest.Positioning the distal end of the viewing device in relation to thedesired target tissue may be accomplished using any convenient approach,including direct linear advance from a percutaneous access point to thetarget tissue. Following positioning of the distal end of the imagingdevice in viewing relationship to the target tissue, the target tissueis imaged through use of the illumination elements and visualizationsensors to obtain image data. Image data obtained according to themethods of the invention is output to a user in the form of an image,e.g., using a monitor or other convenient medium as a display means. Incertain embodiments, the image is a still image, while in otherembodiments the image may be a video.

In embodiments, the internal target tissue site may vary widely.Internal target tissue sites of interest include, but are not limitedto, orthopedic joints, cardiac locations, vascular locations, centralnervous system locations, etc. In certain cases, the internal targettissue site comprises spinal tissue. Orthopedic joints may comprise anytype of joint of interest within the human body, such as the knee or theshoulder. In some embodiments, the internal tissue site may comprisesites of interest during general surgery, such as abdominal organsand/or surrounding tissues.

Further applications of the tissue visualization devices describedherein this section or elsewhere in the specification include use ingeneral surgery (laparoscopic or other minimally invasive surgery) as asecondary visualization device. In some instances, the laparoscopiccamera may need to be removed and the procedure is blind. However, theouter diameters of the devices described herein this application aresmall enough that they can be used to eliminate blackout once alaparoscopic camera is removed. In such embodiments, the elongated bodyis no longer rigid, instead the body is flexible and can be mounted inan elongated flexible tubular body with any of a variety of steeringmechanisms such as one or two or three or more pull wires to deflect thedistal end. In some embodiments, the device may comprise a biased curveddistal end (e.g., Nitinol) that can be selectively curved orstraightened by retracting an outer straight sleeve or internalstraightening wire, etc.

Beyond general surgery and the other applications described herein thissection and elsewhere in the specification, embodiments of thevisualization devices described herein can be utilized in ear, nose, andthroat applications. For example, the devices described herein may beused in any diagnostic evaluation where visualization may be valuable.As another example, the devices described herein may also be used toguide or evaluate the treatment of chronic sinusitis, for instance, thedilatation of a sinus such as the maxillary sinus.

In some embodiments, the subject devices and methods find use in avariety of different applications where it is desirable to image and/ormodify an internal target tissue of a subject while minimizing damage tothe surrounding tissue. The subject devices and methods find use in manyapplications, such as but not limited to surgical procedures, where avariety of different types of tissues may be visualized and potentiallytreated, including but not limited to; soft tissue, cartilage, bone,ligament, etc. Additional methods in which the imaging devices find useinclude those described in United States Published Application No.2008/0255563.

In one embodiment, the imaging device is utilized to accurately positionthe distal end of a needle within the joint capsule in, for example, aknee. This enables injection of therapeutic media into the capsule on areliable basis. For this application, the outside diameter of thetubular body has a diameter of less than about 3 mm, preferably lessthan about 2.5 mm and, in one implementation, approximately 2.1 mm (14gauge).

FIG. 2A illustrates an embodiment of a tissue visualization device 1100,comprising an elongated body 1102 and a handpiece 1104. The elongatedbody may have a length that is at least around 1.5 times longer than itswidth, at least around 2 times longer than its width, at least around 4times longer than its width, at least around 10 times or longer than itswidth, at least around 20 times longer than its width, at least around30 times longer than its width, at least around 50 times longer than itswidth, or longer than 50 times the width. The length of the elongatedbody may vary, and in some instances may be at least around 2 cm long,at least around 4 cm long, at least 6 cm long, at least 8 cm long, atleast 10 cm long, at least 15 cm long, at least 20 cm long, at least 25cm, at least 50 cm, or longer than 50 cm. The elongated body may havethe same outer cross-sectional dimensions (e.g., diameter) along theentire length. Alternatively, the cross-sectional diameter may varyalong the length of the elongated body. In certain embodiments, theouter diameter of the elongated body is approximately 0.1 to 10 mm,approximately 0.5 mm to 6 mm, approximately 1 mm to 4 mm, approximately1.5 mm to 3 mm, approximately 2 mm to 2.5 m, or approximately 2.1 mm. Incertain embodiments, the elongated body is a 14 gauge needle, having anOD of about 2.1 mm and a ID of about 1.6 mm.

In certain embodiments, and as described elsewhere in the specification,the elongated body may have a proximal end 1106 and a distal end 1108.The term “proximal end”, as used herein, refers to the end of theelongated body that is nearer the user (such as a physician operatingthe device in a tissue modification procedure), and the term “distalend”, as used herein, refers to the end of the elongated body that isnearer the internal target tissue of the subject during use. Theelongated body is, in some instances, a structure of sufficient rigidityto allow the distal end to be pushed through tissue when sufficientforce is applied to the proximal end of the elongated body. As such, inthese embodiments the elongated body is not pliant or flexible, at leastnot to any significant extent. In certain embodiments, the distal end1108 can further comprise a sharpened tip as depicted in FIG. 2A,allowing the distal end to pierce through tissue such as a jointcapsule. In certain embodiments, the distal end may be pushed from theexterior of the body into the joint capsule, by piercing through theskin and underlying tissues.

As depicted in FIG. 2A, in embodiments, the handpiece may have a rounded“clamshell” shape comprising a seam 1110 connecting a clamshell top 1112and a clamshell bottom 1114. In some embodiments, the clamshell top 1112and bottom 1114 and can be manufactured in two pieces and then attachedtogether at the seam 1110. The rounded clamshell shape provides acomfortable and ergonomic handle for a user to hold while using thedevice. In certain embodiments and as will be described in greaterdetail later, the handpiece may comprise an image capture control suchas a button 1116 configured to capture a desired image. In furtherembodiments, the image capture control may comprise a switch, dial, orother suitable mechanism. The handpiece 104 may further comprise aretraction control 1118 that retracts or extends a portion of theelongated body 1102 such as a sharpened needle. The retraction controlwill be described in greater detail in relation to FIGS. 2B-C and laterFigures.

In certain embodiments, the control 1116 may selectively activate theacquisition of an image and/or video. The control 1116 may thus beconfigured to selectively start video recording, stop video recording,and/or capture a still image either during video recording or whilevideo recording is off. In some embodiments, the control or anothercontrol may turn on/off an ultraviolet light (UV) source that would beused with UV sensitive material such as a gel. For example, aUV-sensitive liquid could be delivered to a target tissue, such as theknee, followed by application of UV liquid to solidify the liquid into asolid or semi-solid material. UV light may be generated via a standardLED, such as those described elsewhere in the specification. The UVlight could be directed towards the target tissue via illuminationfibers such as those described elsewhere in the specification, whilestill retaining some illumination fibers to illuminate the target tissuefor the purposes of imaging.

In embodiments, the handpiece may comprise a luer connection 1120,configured to connect to any fluid source as described herein thissection or elsewhere in this specification, such as sterile saline. Theluer connection 1120 may be in fluid communication with a lumenextending throughout the length of the elongated body, allowing for thedelivery of fluid or agents to the tissue site.

The junction between the handpiece 1104 and the elongated body 1102 mayinclude a hub 1122 that connects the handpiece 1104 to the elongatedbody 1102. In some embodiments, the hub may be detachable, allowing theelongated body to be detached from the handpiece. In other embodiments,the elongated body is permanently attached to the handpiece via the hubto provide an integrated assembly.

The handpiece may further comprise a strain relief node 1124, configuredto attach to an electrical cable (not shown in FIG. 2A). The strainrelief node 1124 can serve to reduce strain on electrical wiring thatmay be in electrical communication with the handpiece.

In some embodiments, the tissue visualization device 1100 is configuredas an integrated assembly for one time use. In certain embodiments, thetissue visualization device 1100 is pre-sterilized, thus the combinationof integration and pre-sterilization allows the tissue visualizationdevice to be ready for use upon removal from the packaging. Followinguse, it may be disposed. Thus the handpiece 1104, elongated body 1102,and other components, such as the cable, may be all one integrated unit.By one integrated unit, it is meant that the various portions describedabove may be attached together as one single piece not intended fordisassembly by the user. In some embodiments, the various portions ofthe integrated unit are inseparable without destruction of one or morecomponents. In some embodiments, the display, as described herein thissection or elsewhere in the specification, may also be incorporated andsterilized as part of a single integrated tissue visualization device.

FIG. 2B illustrates a cross-sectional side view of an embodiment of thetissue visualization device depicted in FIG. 2A. As in FIG. 2A, thetissue visualization device comprises a number of components such as animage capture trigger 1116, retraction control 1118, luer 1120,elongated body 1102, handpiece 1104, and hub 1122.

In some embodiments, the distal end 1108 may comprise a deflectedconfiguration, in which the distal end of the elongated body inclinesaway from the longitudinal axis of the elongated body 1102. Thisdeflected tip is preferably sharpened, allowing the tip to penetrate atissue site of interest. The deflected tip embodiment of the distal end1108 will be described below in greater detail in relation to FIGS.3A-B. In embodiments, the tip is capable of penetrating through the skinand other tissues to reach an internal tissue site.

As can now be seen in FIG. 3A, the elongated body 1102 comprises anouter tubular body 1126 which may be a hypodermic needle such as a 14gauge needle with a sharpened tip. The visualization element is in theform of an inner optical hypotube 1128 extending concentrically throughthe outer tubular body 1126. The optical hypotube can act to transmit animage of a tissue site to a visualization sensor 1132 (FIG. 2B) such asthose described herein this section and elsewhere in the specification.The handpiece 1104 further comprises a proximal lens housing 1130,described in more detail below in FIG. 7.

In certain embodiments, as described elsewhere, the distal end of thevisualization element may comprises one or more visualization sensors1350, such as any visualization sensor or imaging sensor describedherein this section or elsewhere in the specification. In certainembodiments, one or more visualization sensors may be position on theinner diameter of the outer tubular body. In embodiments where one ormore visualization sensors is positioned on the inner diameter of theouter tubular body, the visualization sensor may be positioned in such amanner as to allow the sensor an angled field of view out of the end ofthe outer tubular body, for example at optional position 1352. In someembodiments, the visualization sensor may be positioned on the innerdiameter of the outer tubular body, opposite the sharpened tip. Thesensor may also be possitioned at any suitable location on the interiorof the outer tubular body to provide a field of view through the distalopeneing of the outer tubular body.

Referring to FIGS. 2C and 3A, as described above, in some embodimentsthe handpiece may comprise a retraction control 1118. The retractioncontrol can serve to retract the outer tubular body 1126 of FIG. 3A,relative to the optical hypotube, thus allowing the optical hypotube toextend beyond the front opening of the outer tubular body at the distalend 1108. See FIG. 3B. In some embodiments, the sharpened distal end isused to pierce the tissue to direct the elongated body into the targetarea. Once the elongated body has reached the target area, such aswithin the joint capsule the retraction control 118 can then be used toretract the sharpened tip proximally of the distal end of thevisualization element. By retracting the sharpened tip, the user maydirect the now blunt distal end of the elongated body within a tissuesite without risk of piercing the tissue again. Retraction of thesharpened tip can be particularly useful for certain tissue sites. Forexample, once a sharpened distal end has pierced the joint capsule of anorthopedic joint, there is risk of piercing through the opposite end ofthe joint capsule. By retracting the sharpened end, images of the jointcapsule can be captured and medication injected without fear of furtherdamaging the joint capsule.

In certain embodiments, the edges and sides of the elongated body andtip are blunted so as not to damage the surrounding tissue whileinserting the elongated body. Blunting of the sharp edges from both theaxial end and the side are critical as the integrated nature of thedevice results in the sharp edges being exposed to the interior anatomy.Similarly, typically a blunt cannula has a removable trocar whichprovides access through the tissue, the trocar then replaced with aseparate camera hypotube.

In some embodiments, blunting is accomplished with the deflectedgeometry of the distal end biasing the optical hypotube against theinner diameter of the outer tubular body. Furthermore, the distal end ofthe outer tubular body may comprise a reverse grind that furtherprotects the sharp edge as the edge is directly against the OD of theoptical hypotube. In some embodiments the outer tubular body maycomprise dimples on either the outer tubular body or the opticalhypotube that would bias the OD of the optical hypotube against the IDof the elongated body. In certain embodiments, there may be one dimple,two dimples, three dimples, four dimples, or more than four dimples. Insome embodiments, the dimples may be replaced or added to with springfingers and/or other secondary parts to bias and direct the opticalhypotube. For example, spring fingers on the hypotube could touch theinner diameter of the outer tubular body. Such fingers or features maymaintain the optical hypotube properly positioned as to direct theoptical hypotube to blunt the sharpened tip. Such fingers or featuresmay be shaped to minimally disrupt the fluid flow. In embodiments, thefingers or features may present a thin cross-section in a directionparallel to the fluid flow, for example as one, two, three, four, ormore “c” shaped features protruding from the outer diameter of theoptical hypotube that are axially long but provide a thin cross-sectionto the fluid.

The reverse grind or reverse bevel feature may be seen with reference toFIG. 3B. The outer tubular body 1126 may be provided with a diagonal cutto produce a primary bevel surface 1416 as is common for hypodermicneedle tips. However, this results in the sharpened distal tip 1410being spaced apart from the interior wall of outer tubular body 1126 bythe thickness of the wall. In that configuration, distal advance of theprobe through tissue can cause tissue to become entrapped in the spacebetween the distal tip 1410 and the outside wall of the optical hypotube 1128.

Thus, referring to FIG. 3B, the outer tubular body 1126 may beadditionally provided with a reverse bevel or tapered surface 1418,inclining radially inwardly in the distal direction, opposing thedirection of the primary bevel 1416. This places the distal sharpenedtip 1410 against the inside wall of the outer tubular body 1126, therebyeliminating or minimizing the risk of tissue injury due to the distaladvance of sharpened tip 1410. The point of sliding contact 1408(discussed below) is located at the distal tip 1410, when the outertubular body 1126 is in the retracted orientation as shown in FIG. 3B,for blunting. The lateral bias of the optical hypo tube 1128 against theouter tubular body 1126, in combination with the reverse bevel 1418produces an atraumatic distal structure.

FIG. 3A depicts an embodiment of the distal end 1108 of the elongatedbody 1102 similar to the embodiments described in FIGS. 2A-C. Theelongated body 1102 may be in the extended position, such as illustratedin FIG. 3A, allowing the sharpened tip 1410 of the distal end 1108 topierce the tissue of interest as described herein this section orelsewhere in the specification. As described above, while in theretracted position depicted in FIG. 3B), the elongated body is lesslikely to further damage the tissue site. Further, the sharpened distaltip 1410 of the elongated body 1108 may have a lateral deflectionrelative to the longitudinal axis of the elongated body 1102, resultingin a deflected tip 1130. In further embodiments, the tip may bestraight. The deflection may be in an upward direction when thehandpiece is oriented as in FIG. 2B with the controls on the top.Deflection may be at least about 1 degree, 3 degrees, 7 degrees, 12degrees, 15 degrees or more from the axis of the elongated body.

The deflected tip 1130 allows a mechanical means of altering thedirection of view of the optical hypotube (such as about 5-6 degrees).In some embodiments, the direction of view may be at least about 3degrees, at least about 6 degrees, at least about 12 degrees, at leastabout 15 degrees, at least about 20 degrees, at least about 30 degrees,at least about 45 degrees, or greater than 45 degrees off the centrallongitudinal axis 1112 of the optical hypotube. Wide angle field of viewcan be accomplished with a lens, or by rotating the fiber optic if thedistal end is deflected off axis. The deflected tip may also providebetter directional performance during insertion and limit the “coring”associated with traditional needle geometry (minimizing the chance thata skin core will be dragged into the patient and potentially cause aninfection).

With continuing reference to FIG. 3A, The elongated body 1102 may besubstantially linear throughout at least about the proximal 65% and insome implementations at least about 80% of the axial length, with adeflected distal segment 1108 as has been discussed. Disregarding thedeflection, the elongated body 1102 may be characterized by a centrallongitudinal axis 1104 from which the distal segment 1108 deviateslaterally.

In the illustrated embodiment, the degree of deflection of the distalsegment 1108 positions the distal sharpened tip 1410 approximately inalignment with the central longitudinal axis 1404. Thus the lateraldisplacement 1406 resulting from the deflection in the illustratedembodiment is approximately 50% of the outside diameter of the elongatedbody 1102. The lateral displacement 1406 is generally no more than aboutthe outside diameter of the elongated body 1102, and in manyimplementations is at least about 10% and sometimes at least about 25%of the OD of the elongated body 1102. In certain implementations of theinvention, the lateral displacement 1106 is within the range of fromabout 40% to about 60%, and sometimes between about 45% and 55% of theOD of elongated body 1102.

The foregoing tip configuration allows the elongated body 1102 topenetrate through tissue along a substantially linear axis, while at thesame time launching the distal tip of the optical hypotube with alateral inclination. Since the optical hypo tube 1128 is substantiallylinear, and the elongated body 1102 is provided with the deflecteddistal segment, a point of sliding contact 1408 is created between adistal edge of the optical hypo tube 1128 and an inside surface of theelongated body 1102. The lateral inclination of the outer tubular body1126 causes the optical hypo tube 1128 to bend laterally as the outertubular body 1126 is withdrawn proximally with respect to optical hypotube 1128. This result may alternatively be accomplished by providing apreset lateral deflection in a distal segment of the optical hypotube,in combination with an outer tubular body having either a deflected orsubstantially linear distal segment 1408.

The effect of the foregoing geometry, as has been briefly discussed, isto enable a mechanical broadening of the lateral field of view. Opticalbroadening of the field of view may alternatively or additionally beaccomplished, using a variety of optical lens systems well known in theart.

Referring to FIG. 3B, the optical hypo tube 1128 will enable viewingalong a primary viewing axis 1412. Depending upon the distal optics ofthe optical hypo tube, the primary viewing axis 1412 will typicallylaunch at a perpendicular angle to the distal optical surface, andreside on a center of rotation of a typically substantially conicalfield of view 1414. The geometric shape of the field of view 1414 may bemodified, as desired, such as to oval, rectangular or other shape eitherthrough optics or software.

The lateral deflection of the primary viewing axis 1412 may bequantified, among other ways, by identifying an angle theta between thecentral longitudinal axis 1404 of the elongated probe body 1102 and theprimary viewing axis 1412. The angle theta may be at least about 1°, atleast about 3°, at least about 7°, at least about 12°, at least 15degrees, or more, but typically no more than about 45°, and in certainembodiments, at least about 3° and no more than about 8° or 10°.

The field of view 1414 may be characterized by an angle alpha, whichwill depend primarily upon the distal optics 1136. The angle Alpha willtypically be between about 45° and about 120°, such as between about 55°and 85°. In one implementation, the angle Alpha is approximately 70°.

As will be appreciated by reference to FIG. 3B, the field of view Alphaenables lateral deflection of the primary viewing axis 1412 throughout arange to enable lateral viewing, while still permitting the centrallongitudinal axis 1104 to intersect target tissue at a point thatremains within the field of view 1414. This enables visualizationstraight ahead of the tubular body, along the central longitudinal axis,while at the same time permitting increased lateral viewing in the angleof deflection. Rotation of the elongated body 1102 about the centrallongitudinal axis 1404 therefore enables sweeping the optical field ofview through a range of rotation which effectively increases the totalvisualized target size. For example, in an embodiment having a field ofview of 70°, and a deflection of 5°, rotation about the centrallongitudinal axis 1404 throughout a full revolution enables sweepingthrough an effective field of view of 152°.

In some embodiments, the elongated body 1102 comprises a lumen 1138 thatmay deliver fluid including medications such as anti-inflammatoryagents, antibiotics, anesthetics or others known in the art within thecapsule or to other tissue site. In certain embodiments, as depicted inFIG. 3A, the lumen 1138 may encompass the annular space between theoptical hypotube 1128, and the outer tubular body 1126.

In some embodiments, the distal end of the visualization element maycomprise a distal lens 1136 configured to facilitate the imaging of aninternal tissue site. The distal lens, or any other lens, may developdefects and imperfections during manufacturing, leading to a distortionin the image. These distortions may be unique to individual lenses andthus in the case of the embodiments disclosed herein this application,may be unique to an individual tissue visualization device. Thus, toenhance image quality, the device 1100 as depicted in FIG. 2A, mayinclude an automatic optical correction in the form of a uniquealgorithm. In some embodiments, the algorithm may be stored in a chip orother suitable means within the handpiece 1004.

In certain embodiments, the automatic optical correction may serve toimprove the image quality generated by the tissue visualization device.The Abbe number, also known as the V-number or constringence of atransparent material, is a measure of the material's dispersion(variation of refractive index with wavelength) in relation to therefractive index, with high values of V indicating low dispersion (lowchromatic aberration). Low chromatic aberration is desired to optimizeimage quality, but achieving low chromatic aberration normally increasesmanufacturing cost. In some embodiments, chromatic aberrations in thetissue visualization device may be corrected via the aforementionedsoftware algorithm at the time of clinical use, which allows economiesduring manufacturing. For example, the optical correction may allow forvisualization performance from the device with less expensive lensesthat rivals the performance of visualization devices that use far moreexpensive lenses with minimal imperfections.

In embodiments, to generate the algorithm at the point of manufacture,the distal optic is focused on a known definition pattern. A computercan then compare the captured image to the known pattern and create analgorithm that restores the captured image to the true definitionpattern. As described above, that algorithm may then be stored in a chipin the handpiece 1104.

When the handpiece 1104 is connected to a displayer 6 at the clinicalsite, as described previously in relation to FIG. 1, the algorithmserves as the basis for the displayer 6 to correct the captured imagesuch that aberrations in the optical system are removed. Each individualtissue visualization device will have unique aberrations, so eachhandpiece will carry a unique algorithm designed to correct that system.

Returning to FIG. 3B, FIG. 3B further depicts a closer view of anembodiment of the sharpened distal end 1204 of the elongated body in theretracted position. As described above, in relation to FIG. 2C, theretraction control serves to retract the sharpened deflected tip 1204 toprevent further damage to the surrounding tissue while viewing aninterior tissue site.

As shown in FIG. 3C, in certain embodiments of the distal end of theelongated body 1700, the distal end of the optical hypotube 1702 may beflared 1706 to accommodate a larger sensor 1708 positioned at the distalend of the optical hypotube 1702 than would ideally fit into thediameter of a standard hypotube 1704. This flare could simply be alarger diameter cross-section, a square cross section or something tomatch what is within. The axial length of this flare would be toaccommodate the length of the sensor plus routing of illumination fiberaround the sensor and would have a transition zone back to the circularcross section of the normal hypotube. In certain embodiments, this maybe accomplished with a non-circular cross-section. The sharpened tip mayalso need to would also be flared with or without a gap to provide alumen between the optical hypotube's “OD” and the elongate member's“ID”. In certain embodiments, the outer tubular body may be curved suchas disclosed herein this section or elsewhere in the specification orthe outer tubular body may be straight to accommodate the flared tip.

As described above in relation to the “flared” embodiment, in order tominimize the overall size of the product/needle, the inner diameter (ID)of the outer tubular body may be sized so that it is completely “filled”by the outer diameter (OD) of the flared distal end of the opticalhypotube. In embodiments, the flared geometry restricts the inner lumenand prevents the passage of fluid from the end of the outer tubularbody.

In embodiments, to allow for fluid flow, the axial length of the flaregeometry may be designed to be shorter than the translation distance ofthe outer tubular body 1710. When the outer tubular body is in theforward or sharp position, the flare is contained within the innerdiameter of the tubular body and flow is restricted through the lumen1712. However, when the tubular body is the retracted position (andblunted), the flared portion of the hypotube completely protrudes out ofthe open bevel of the tubular body, thereby allowing the effective lumenof the device to be between the normal cross-section of the hypotube andthe ID of the needle. In some embodiments, the outer tubular body maycontain axial holes to allow for fluid flow from the lumen in adifferent direction and location from the open end of the elongate body.

FIG. 4 depicts a cross-sectional top view of an embodiment of the tissuevisualization device 1100. The handpiece 1104 comprises an illuminationelement 1134 and a visualization sensor support 1180, described ingreater detail below. Similar to illumination elements or apparatusesdescribed elsewhere in this specification, the illumination element 1134may extend down the length of the elongated body and convey light downthe elongated body to an interior tissue site to allow for visualizationof the target tissue. In some embodiments, the illumination element 1134comprises a bundle or bundles of illumination fibers.

FIG. 5 illustrates cross sectional views of an embodiment of a tissuevisualization device down the length of an elongated body 1200, similarto the elongated bodies depicted in FIGS. 2A-4. In certain embodiments,the optical hypotube 1204 may comprise an image guide 1202, at least oneillumination fiber or fiber bundle 1210, an infusion lumen 1206, andouter tubular body 1208. As will be understood by one skilled in theart, the use of the term “illumination fiber” here encompasses anillumination fiber or fiber bundle. As described elsewhere in thespecification, the illumination fibers or fiber bundles may beconfigured to transmit a wavelength of light suitable for illuminating atarget tissue for visualization; however, the illumination fibers mayalso be configured to transmit UV light to a tissue site for the purposeof solidifying a UV-sensitive material. For example, if there are 14total illumination fibers or fiber bundles, then 7 may be configured todeliver light suitable for visualization while another 7 may be suitablefor delivering UV light. However, any suitable combination may be used.For example, most of the illumination fibers may be UV, half of theillumination fibers, or less than half. In particular embodiments, thenumber of illumination fibers may be increased or decreased from thenumber depicted in FIG. 5. For example, there may be one fiber, at leasttwo fibers, at least 5 fibers, at least 10 fibers, at least 14 fibers,at least 20 fibers, at least 25 fibers, at least 50 fibers, or more than50 fibers. In certain embodiments, the illumination fibers may beconfigured to output multiple wavelengths of light suitable for imagingan internal tissue site.

The wavelength of light delivered via illumination fibers 1210 [whichcan be at least 4, 8, 12 or more fibers or bundles of fibers, and whichmay be arranged in an annular configuration surrounding the image guide1202 as shown in FIG. 5 but described in detail below] may be selectedfor various wavelength specific applications. For example, wavelengthsin the UV range can be utilized to permit visual differentiation oftissue types such as to distinguish nervous tissue from surroundingtissue and/or minimally vascularized nervous tissue. Blood vessels mayappear to have a first color (such as red) while nerve tissue may appearto have a second color (such as blue). The wavelength may also beoptimized to distinguish nervous tissue from muscle.

In another application, light such as UV light or visible light may bepropagated via fiber 1210 to promote or initiate curing of an infusedsolution (e.g., via polymerization or cross-linking), where the solutionor gel is administered via infusion lumen 1206, to form a solid orsemi-solid mass in vivo. The mass may be a tissue bulking device,coating layer or other structural element.

Another wavelength specific application involves directing a preselectedwavelength to a target impregnated with a drug or drug precursor. Upondelivery of the preselected wavelength to the target, drug is released,or the precursor is converted into a drug which is then released. Thetarget may be an implanted mass or device, or an infused carrier mediumsuch as any or a combination of a liquid, gel, or beads.

The UV light may include Ultraviolet A, long wave, or black light,abbreviated “UVA” and having a wavelength of 400 nm-315 nm; Near UVlight, abbreviated “NUV” and having a wavelength of 400 nm-300 nm;Ultraviolet B or medium wave, abbreviated “UVB” and having a wavelengthof 315 nm-280 nm; Middle UV light, abbreviated “MUV” and having awavelength of 300 nm-200 nm; Ultraviolet C, short wave, or germicidal,abbreviated “UVC” and having a wavelength of 280 nm-100 nm; Far UVlight, abbreviated “FUV” and having a wavelength of 200 nm-122 nm;Vacuum UV light, abbreviated “VUV” and having a wavelength of 200 nm-400nm; Low UV light, abbreviated “LUV” and having a wavelength of 100 nm-88nm; Super UV light, abbreviated “SUV” and having a wavelength of 150nm-10 nm; and Extreme UV light, abbreviated “EUV” and having awavelength of 121 nm-10 nm. In some embodiments, the catheters mayinclude an element that emits visible light. Visible light may includeviolet light having a wavelength of 380-450 nm; blue light having awavelength of 450-475 nm; cyan light having a wavelength of 476-495 nm;green light having a wavelength of 495-570 nm; yellow light having awavelength of 570-590 nm; orange light having a wavelength of 590-620nm; and red light having a wavelength of 620-750 nm. In someembodiments, the catheter includes an element that emits light having awavelength between about 300 nm and 500 nm. In particular, the cathetermay include an element that emits light having a wavelength associatedwith blue light (e.g., light having a wavelength between about 450-475nm). Wavelength selection information and characterization and otherdetails related to infrared endoscopy are found in U.S. Pat. No.6,178,346; US Patent Application Publication No. 2005/0014995, and USPatent Application Publication No. 2005/0020914, each of which is herebyincorporated by reference in its entirety.

In certain embodiments, the outer diameter of the optical hypotube mayrange from approximately 0.1 mm to 3 mm, approximately 0.5 mm to 2.5 mm,or approximately 1 mm to 2 mm. In certain embodiments, the outerdiameter of the optical hypotube is approximately 1.27 mm. In someembodiments, the inner diameter of the outer tubular body ranges fromapproximately 0.1 mm to 10 mm, approximately 0.2 mm to 8 mm,approximately 0.5 mm to 6 mm, approximately 1 mm to 5 mm, approximately1.2 mm to 4 mm, or approximately 1.4 mm to 3 mm. In certain embodiments,the inner diameter of the outer tubular body 1208 is approximately 1.6mm.

In some embodiments, the image guide 1202 allows for the viewing of animage of the tissue site by the visualization sensor in the handpiece.In particular embodiments, the image guide may be a fiber optic or othersuitable medium to allow for imaging of the tissue site by avisualization sensor as described herein this section or elsewhere inthe specification. The fiber optic bundle may have at least about 6K, orat least about 10K or at least about 15K or at least about 30K fibers ormore, depending upon the desired performance. In some embodiments, theimage fiber may be a 6.6 k fiber bundle or a 10 k fiber bundle.

FIGS. 6A-C illustrate embodiments of the elongated body and innercomponents of a tissue visualization device 1300, similar to theembodiments depicted elsewhere herein. In this particular figure, theouter shell of the handpiece is removed to better view the interior ofthe device. In certain embodiments, the tissue visualization devicecomprises an elongated body 1302, an illumination element 1304, lightsource housing 1306, a proximal lens housing 1310 m a ferrule 1314, anosepiece 1312, and a distal lens 1316.

FIG. 6B illustrates a top view of the tissue visualization device 1300of FIG. 6A, while FIG. 6C illustrates a side view. The components inthese figure are similar to the components illustrated in 6A, however in6B, the visualization complex is identified as 1318. The visualizationcomplex and surrounding components can be viewed in more detail in FIG.7.

FIG. 7 illustrates a cross-sectional side view of an embodiment of thevisualization complex of FIG. 6C. In some embodiments, the visualizationcomplex 1318 may comprise a visualization sensor 1320 such as thosevisualization sensors described herein this section or elsewhere in thespecification. In certain embodiments, the visualization sensor may be aCMOS sensor as described herein this section or elsewhere in thespecification.

In certain embodiments, the visualization complex can comprise a firstlens 1322, an optical aperture 1324, and a second lens 1326. In someembodiments, the aperture may have a diameter of at least about 0.1 mm,at least about 0.2 mm, at least about 0.3 mm, at least about 0.5 mm, ormore than 0.5 mm. Preferably, the aperture may be approximately 0.222mm. To support the lenses, the visualization complex may comprise aproximal lens housing as described previously, wherein the proximal lenshousing may serve to secure the lenses 1320 and 1326 in the properlocation and orientation. The visualization complex may further comprisean image guide, similar to the image guide described previously inrelation to FIG. 5.

As illustrated in FIG. 1 and FIG. 8A, one consequence of the integratedvisualization device of the present invention is that rotation of thevisualization device 4 about the central longitudinal axis 1404 toachieve the enlarged field of view will simultaneously cause a rotationof the apparent inferior superior orientation as seen by the clinicianon the display such as video screen 19 of FIG. 1 or image 1501 of FIG.8A. It may therefore be desirable to compensate such that a patientreference direction such as superior will always appear on the top ofthe screen 19, regardless of the rotational orientation of thevisualization device 4, such as depicted in image 1503 of FIG. 8B.

This may be accomplished by including one or more sensors or switchescarried by the visualization device 4, that are capable of generating asignal indicative of the rotational orientation of the visualizationsensor 1132. The signal can be transmitted via wire or wireless protocolto the controller 6 for processing and correction of the rotationalorientation of the image on screen 19 or other display, to stabilize theimage.

Suitable sensors may include simple tilt or orientation sensors such asmercury switches, or other systems capable of determining rotationalorientation relative to an absolute reference direction such as up anddown. Alternatively, the rotational orientation image correction systemmay comprise a 3-axis accelerometer with associated circuitry such as asmall accelerometer constructed with MEMS (micro-electro mechanicalsystems) technology using capacitance measurement to determine theamount of acceleration, available from Freescale Semiconductor, Inc., ofAustin, Tex. and other companies.

As an alternative or in addition to the accelerometer, the visualizationdevice may carry a gyroscope such as a three-axis gyroscope. The outputof the gyroscope may be the rate of change of roll angle, pitch angleand yaw angle and rotational rate measurements provided by the gyroscopecan be combined with measurements made by the accelerometer to provide afull six degree-of-freedom description of the sensor 1132's motion andposition, although that may not be necessary to simply correct forrotational orientation. A control may be provided on the hand piece orcontroller 6, allowing the clinician to select what referenceorientation (e.g., patient superior, inferior, true up or down, etc. ortrue sensor view such that the image on the screen rotates with thesensor) they would like to have appearing at the top of the screenregardless of sensor orientation. In certain embodiments, markers suchas an arrow or line may be projected onto the image to further identifydifferent orientations and/or directions

In some embodiments, the optical hypotube may be sheathed in heat shrinktubing. For example, the outer tubular body as described elsewhere inthe specification, may be constructed from a heat-sensitive material.Thus, to construct the elongated body as described elsewhere in thespecification, the optical hypotube and other components may be extendeddown an over-sized outer tubular body which is then shrunk down to thediameter of the optical hypotube via means such as heat, UV, chemical,or other means. In contrast, traditional endoscopes and some endoscopesdescribed elsewhere in the specification house the optics in a rigidstainless steel tube. However, housing the optics within a stainlesssteel tube may require forcing many optical and illumination fibers downa very tight ID and then applying an adhesive such as epoxy. Such aprocess is difficult and costly.

FIGS. 9A-D illustrate an embodiment of a visualization device, similarto the visualization devices in FIGS. 1-7. The visualization device ofFIGS. 9A-D incorporate at least one mirror to alter the viewingdirection and field of view of the visualization device. FIG. 9A depictsa reflective plug 1600 which may be inserted into the distal end of atubular body, such as the tubular bodies described above in relation toFIGS. 1-3B. Such a plug may comprise a mirrored surface 1602 that willreflect an image at a particular angle 1604, for example, providing adirection of view 30 degrees from the axis of the plug. In someembodiments, the angle may be much smaller, such as between 0-15degrees. In further embodiments the angle may range from 15-45 degrees.In some embodiments, the angle may be at least 45 degrees, at least 60degrees, at least 75 degrees or at least 90 degrees or more. Asillustrated in FIG. 9B, and described above in relation to FIG. 9A, theplug 1600 may be inserted into the end of a tubular body 1606, similarto the tubular bodies described elsewhere in the specification. Inembodiments, the plug may be incorporated into any of the visualizationdevices described elsewhere in the specification. In some embodiments,the plug may be sharpened to allow the plug to pierce tissues.

FIGS. 9C-D illustrate embodiments of the outer tubular body of FIG. 9Bcomprising a gap 1608. The gap allows for light to reflect from themirrored surface 1602 and be directed down the tubular body 1606,thereby transmitting an image of the field of view available through thegap down the elongated body. Such an image may be transmitted along anoptical hypotube and/or image guide such as described elsewhere in thespecification. Further components, such as illumination elements may beused to direct light along the mirrored surface and out through the gapto illuminate surrounding tissues. In embodiments, the gap may allow fora field of view 1610 that extends forward and above the distal end ofthe tubular body. Depending on the angle and orientation of the mirroredsurface, the magnitude of the field of view may be between about 45° and120°, such as between about 55° and 85°. In one implementation, theangle may be approximately 70°.

In embodiments, the visualization devices of FIGS. 9A-D may bemanufactured from a variety of means. For example, a tubular reflectivematerial such as depicted by reflective plug 1600 may be sliced at adesired angle and milled/polished to create a mirrored surface 1602.Such a plug with a mirrored surface may be fed through an open end of atubular body with a cut gap 1608, such as tubular body 1606 of FIGS.9B-D, and welded to the tubular body. Once the mirrored surface isproperly positioned within the tubular body, the tubular body andreflective plug may be cut/milled at the same time to create a sharpenedtip 1612, such as illustrated in FIG. 9D.

In certain embodiments, a desired direction of view may be reached bypositioning a prism at the distal end of the elongated body. Such aprism may provide a direction of view such as disclosed elsewhere in thespecification, for example: providing a direction of view 30 degreesfrom the axis of the elongated body. In some embodiments, the angle maybe much smaller, such as between 0-15 degrees. In further embodimentsthe angle may range from 15-45 degrees. In some embodiments, the anglemay be at least 45 degrees, at least 60 degrees, at least 75 degrees orat least 90 degrees or more.

In some embodiments, the elongated body may be in a shape that isnon-circular. For example, the entirety of the elongated body may beoval or elliptical in shape. In some embodiments, only the distal end ofthe elongated body is oval-shaped while the remainder of the elongatedbody is circular. An oval shaped elongated body advantageously allowsfor additional space for the deflected distal tip. In certainembodiments, the major axis of the ellipse is approximately 1.1 times aslong as the minor axis. In some embodiments, the major axis is at least1.2 times, 1.3 times, 1.5 times, 1.75 times, 2 times, 3 times, 4 times,5 times, or more than 5 times as long as the minor axis.

In particular embodiments, the distal tip of the elongated body may beconstructed from elastic material to allow the distal tip to flexdistally. Further, the deflected portion of the distal tip may be veryshort, allowing the deflected portion to stay within the outer perimeterconfines of the elongated body.

In certain embodiments, the distal end of the elongated body may berotated with respect to the optical hypotube. For example, the sharpeddistal point may be under the optical hypotube, over the top of theoptical hypotube, or on with side of the optical hypotube. In certainembodiments, the optical hypotube may act as a shield to prevent thesharpened distal point from damaging the surrounding tissue in anyorientation. In certain embodiments, the optical hypotube may comprise ashield at the distal tip, the shield acting to protect the surroundingtissue from the sharpened distal tip of the elongated body. Uponrotation of the optical hypotube, the shield may be moved from thesharpened distal tip of the elongated body, allowing for furtherpenetration through tissue.

FIG. 10A illustrates an embodiment of the distal end of a tissuevisualization device, similar to the tissue visualization devicesdepicted in FIGS. 1-9. Here, the arrow “C” indicates the distaldirection towards the tissue site. The distal end of the elongatedmember 5 comprises an optical fiber 3, similar to the optical hypotubesand optical elements described elsewhere in the specification. Distallens 2 may comprise any type of lens described herein this section orelsewhere in the specification, including a GRIN (Gradient-index) lens.The lens may have a diameter of between about 100-700 microns, about200-600 microns, about 400-500 microns, or about 465 microns.

In certain embodiments, as depicted in FIG. 10A, the distal end of thetissue visualization device may include a circular transparent plate 12,such as a glass plate or other suitable transparent material. In theembodiment depicted in FIG. 10A, the plate is non-powered, however insome embodiments the plate may be powered to have magnification levelsof about 2×, 4×, 10×, 20×, 100×, or greater than 100×. The plate may beflat on both sides of the plate, rounded on both sides of the plate, orrounded on one side and flat on the other side. In certain embodiments,the plate may have a diameter of between about 100-700 microns, about200-600 microns, about 400-500 microns, or about 465 microns. In certainembodiments, an adhesive 11 adheres the plate to the distal lens 2, andthe distal lens 2 adhered to the optical fiber 3 by another adhesive.

In embodiments, and as depicted in FIG. 10A, the plate 12 may include amask 13 on the proximal side of the plate, surrounding a transparentwindow 14. However, in certain embodiments, the mask may be on thedistal side of the plate. By placing the mask on the proximal side ofthe plate, potentially toxic mask materials are prevented frominteracting with tissue. The mask may comprise any suitable materialthat limits transmission of light such as a chrome coating. However, anysuitable evaporative coating may be used such as different metallicmaterials.

The window encompasses an area of the plate not covered by the mask,thereby allowing light to pass through the window. As described in moredetail in relation to FIG. 12 below, the mask may be applied in anannular region of the plate, thereby creating a rounded window 14.

In particular embodiments, the mask acts to limit the transmission oflight through the plate, for example the mask may restrict the gatheringof all the angles of light reflecting from the object being viewed (e.g.tissue site). The overlap of light rays on the image is therefore verysmall and the result is a sharper image over a wider depth of field.Although this may reduce the brightness of the image, the image is muchsharper. In certain embodiments, the material of the mask allows at mostabout 0% transmission of light through the material, about 2%, about 4%,about 5% or about 10%. Further, the mask preferably absorbs light ratherthan reflects light to limit stray light from affecting the sharpness ofthe image. In embodiments, the material of the mask may reflect at mostabout 0% of the light impacting the surface, about 5%, about 10%, about20%, about 25%, or about 30%. In certain embodiments, the reflectivityat 400 nm of light may be 12%, at 500 nm-20%, at 600 nm-27%, at 700 nm33%.

The circular plate may be sized to have the same diameter as the lens 2,however, in embodiments the plate may be smaller than the lens 2, suchas at least about: 10% of the size of the lens, 25%, 50%, 75%, or 90%.When the plate is smaller than the lens, light may potentially leakthrough the plate into the lens, thus in these scenarios an opaqueadhesive or cover may be applied to the distal end of the lens to limitthe passage of light into the lens. In certain embodiments, the platemay be non-circular such as rectangular or polygonal. As with thecircular plate, the non-circular plate may be about: 10% of the size ofthe lens, 25%, 50%, 75%, or 90%. As with the smaller rounded plate, thenon-covered regions of the lens may be coated in an opaque adhesive tolimit the transmission of light.

In certain embodiments, rather than using a transparent plate with amask, the plate may be replaced with any suitable material comprising anaperture. For example a metal plate with a window may be used, or anopaque polymeric material.

Commonly in the field of imaging, when using a GRIN lenses such as thosedescribed herein this section or elsewhere in the specification, anoptical mask such as described above in relation to the plate, wouldnormally be placed between two GRIN lenses or at the focus point of thelens, however, here the mask is positioned between a non-powered plateand a powered lens. Further, although the mask may be placed in thefocal point of the lens, here the mask need not be located at the focalpoint.

FIG. 10B illustrates a side and front view of embodiments of thevisualization device, similar to the embodiments depicted in FIG. 6A.

In further embodiments, a cmos/ccd sensor may be located at the distaltip of the visualization device rather than a proximal location. With adistally mounted sensor, distally located LEDs may be utilized with orwithout a short light pipe rather than relying on illumination fibers totransmit the light from a proximal led.

FIG. 10C illustrates a view along the elongate member of thevisualization device, such as is depicted in FIG. 5. Illumination fibers10 are secured within epoxy around a central optical element and/orimage guide.

In certain embodiments, the illumination fibers can also be bunched toone side of the tube with the imaging lens and fiber on the oppositeside (the drawing has them around the circumference but may also beasymmetric. The claims also talk about the ratio of the window to thefiber but the ratio is more appropriate to the diameter of the Lens.

FIG. 11 compares pictures of the interior of a red pepper imaged with avisualization device comprising the plate described above and avisualization device without the plate. As can be viewed in the image,the addition of the plate dramatically improves the sharpness of theimage.

FIG. 12 depicts a plate 2000 such as the plate described above inrelation to FIG. 10. Here the mask 2002 is annular and surrounds atransparent window 2004 that allows the passage of light. Although herethe mask and window are depicted as annular, in other embodiments themask and window may be rectangular, triangular, octagonal, or in theform of other suitable polygons. In certain embodiments the mask maycover at most: about 25% of the surface of a single side of the plate,about 50%, about 60%, about 70%, about 80%, about 90%, or about 95% ofthe surface area of one side of the plate. In some embodiments, asdescribed above, the plate may have a diameter of about 0.5 mm or anydiameter described above, however, the window 2004 may have any suitablediameter corresponding to the percentages described above, for examplethe window may have a diameter of between about 50-200 microns, 75-150microns, or about 100-125 microns. For example the diameter may be 90microns, 130 microns, or 150 microns.

In certain embodiments, the ratio between the diameter of the activearea of the imaging element/imaging fiber to the diameter of the windowmay be approximately at least: about 2×, about 3×, about 4×, about 5×,about 6×, about 8×, about 10×, or more than 10×. In certain embodimentswhere the window is non-circular, the ratio of the area of the window tothe active area of the imaging element or imaging fiber may be at leastabout 5×, about 10×, about 15×, or about 20×.

FIG. 13A depicts an embodiment of an inner optical hypotube 3002,similar to the optical hypotubes depicted previously in FIGS. 3A-6C.Here, the optical hypotube is shown without the outer tubular body;however, in use the optical hypotube would be contained within an outertubular body as shown in FIGS. 3A-6C. In embodiments, the opticalhypotube may have a bend 3004, the bend biasing the distal end 3006 ofthe optical hypotube against the outer tubular body, when the opticalhypotube is contained within an outer tubular body. In certainembodiments, the bend may be positioned about 50% down the length of theof the optical hypotube from the handpiece, about 60%, about 70%, about80%, or about 90%. In certain embodiments the bend may be a gradualbend, wherein other embodiments the bend may be a sharp bend. Inembodiments, there may be a single bend, two bends, three bends, fourbends, five bends, or more than five bends. In certain embodiments, abend may have a degree of bending of at least about: 1 degree, 5degrees, 10 degrees, 15 degrees, 25 degrees, 35 degrees, 45 degrees, 50degrees, 60 degrees, 75 degrees, or 90 degrees.

13B is a photograph of embodiments of the optical hypotube 3002 side byside with an embodiment of an outer tubular body 3006, similar to theouter tubular bodies depicted previously in FIGS. 3A-6C. Here, the bend3004 is fairly gradual, biasing the tip 3006 against the sharpeneddistal end of the outer tubular body 3008. FIG. 13C further depictsembodiments of the optical hypotube 3002 and the outer tubular body3008, however, here the needle hub assembly 3012 and the electro-opticalassembly 3010, similar to the embodiments described above in relation toFIGS. 1-7.

FIG. 14A is a close-up photograph of an embodiment of the distal end ofthe elongate body 3100, similar to those described previously,comprising outer tubular body 3104 and optical hypotube 3102. Here, theouter tubular body 3104 is retracted and blunted as will be describedfurther below. As described previously, the elongate body has a reversegrind 3106 bringing the needle point 3108 closer to the opticalhypotube. As shown in FIGS. 13A-C, the Optical Hypotube bending biasesit against the inner diameter of the outer tubular body 3104, closest tothe point of the sharpened tip 3108. As shown in previous embodiments,when the outer tubular body is retracted, it is blunted against theoptical hypotube 3102. FIG. 14B depicts a close-up view of an embodimentof the distal end of the outer tubular body 3104, similar to theembodiments described previously. Here, the reverse grind on the outertubular body, raises the sharpened tip upward, allowing the sharpenedtip to be better blunted by the optical hypotube. In certainembodiments, the reverse grind may raise the sharpened tip upward byangle 3110. In certain embodiments, the angle may be about: 5 degrees,10 degrees, 15 degrees, 25 degrees, 30 degrees, 45 degrees, 60 degrees,75 degrees, 90 degrees, or more than 90 degrees.

In certain embodiments, the blunting contact between the opticalhypotube 3102 and the outer tubular body 3104 may generate a tangentialcontact force. In some embodiments, a Huber type bend in the outertubular body may result in tangential contact with the optical hypotubeand deflect the hypotube to provide a contact force that providesblunting as the resistance to this force needs to be overcome before theoptical hypotube no longer blunts the sharpened tip. In certainembodiments, the outer tubular body may comprise a long bend in needleto bias the optical hypotube towards the direction of bend of the outertubular body for example, in certain embodiments, a bend may have adegree of bending of at least about: 1 degree, 5 degrees, 10 degrees, 15degrees, 25 degrees, 35 degrees, 45 degrees, 50 degrees, 60 degrees, 75degrees, or 90 degrees.

In certain embodiments, a thin-wall component may be attached to theoptical hypotube to bias the optical hypotube in a certain directionand/or orientation. This component may have a larger diameter than thedistal portion of the optical hypotube and could optionally be attachedto the outer surface of the optical hypotube, for example at apoint/line on the lower most portion of the outer diameter. Thiscomponent may be in the form of a tube along the outside of the opticalhypotube but in certain embodiments may have portions removed tominimize the impact to the lumen or fluid path. In certain embodiments,the thin wall component could be located at position proximal to theflare in the optical hypotube. Low profile “fingers” may be used tocenter the hypotube within the needle.

FIG. 15 is a flowchart showing an embodiment of a method for treating atissue site in the knee using the apparatuses disclosed herein thissection and throughout the specification. However, as will be understoodby one of skill in the art, the method may be suitable for any type ofjoint and other tissue types. For example, the method may rely upontissue visualization devices and systems such as shown in the previousfigures, such as FIG. 1. In the first step, 3202, the patient may bepositioned either supine or seated, with a joint in slight flexion. Inthe second step 3204, the portal site is prepared with a local asepticsolution. Next analgesic is delivered to the joint 3206 and the joint isfilled with a minimum of 30 cc of sterile fluid. In the fourth step3208, the controller and viewing screen are turned on and thevisualization device is connected to the controller and screen.Additionally, a stopcock and syringe may be attached to thevisualization device. Next, the visualization device is inserted intothe inferolateral or inferomedial portal, based on suspected pathologyand guided to the tissue site 3210. The visualization device may beinserted directly into the lateral or medial compartment, avoiding the“notch” and fat pad. Once inside the joint capsule, the sharpened tip ofthe outer tubular body or “needle” is retracted via the retractionbutton 3212. Lastly, a medical practitioner may perform an exam 3214using the visualization device by applying varus and valgus tension onthe tibia to allow for medial and lateral distention. Further, extendingthe knee allows for the posterior compartment to be more easilyvisualized. Additional sterile saline may be injected at any time asneeded throughout the exam to clear the field of view.

In certain embodiments, while the visualization device is navigatingtoward the tissue site, the optical hypotube may remain retracted withinthe outer tubular body, allowing for a “tunnel” view of the tissueoutside the outer tubular body. This approach advantageously reducessoft tissue interaction with the optical hypotube and provides an offsetfrom the distal end, allowing for improved visualization in some cases.In certain embodiments, additional fluid may be added to the joint (suchas a knee) to improve visualization by clearing debris and creatingspace for the optical components. Fluid may be added to the knee via asecondary needle to pre-condition the knee for visualization, prior toinsertion of the visualization device. In some embodiments, fluid may beadded to the knee through the visualization device while the outertubular body is still in the forward position. Constant fluid may alsobe added via a syringe, such as by the physician or via an extensiontube plus syringe depressed by an assistant. In some embodiments, shortbursts of fluid (1-2 ml) may be applied to clear the area immediately infront of the visualization device.

FIG. 16 depicts an embodiment of a visualization sensor 3202 positionedat the distal end of an elongated body 3300 within the optical hypotube3306 and outer tubular body or needle 3304, similar to the elongatedbodies found in the visualization devices depicted in FIGS. 1-7. Here,the sensor 3302 is rotated approximately 30 degrees from thelongitudinal axis of the elongated body. However, in some embodiments,the visualization sensor may be rotated at least about 5 degrees, 10degree, 15 degree, 20 degrees, 30 degrees, 45 degrees, 60 degrees, 75degrees, 90 degrees, or more than 90 degrees. In certain embodiments,such as described previously, the optical hypotube could also have aflared outer diameter at the distal tip, such as disclosed herein thissection or elsewhere in the specification, but could also be straight asshown. As with the embodiments depicted previously in the specificationin relation to the previous figures, illumination may be provided byvarious means such as via an optical fiber and/or discrete LEDspositioned at the distal end of the elongated body. The optical fiberand or LEDs may be oriented in the same axis as the visualizationsensor, or in a different axis.

FIG. 17 depicts an embodiment of a visualization device, similar to thevisualization devices of FIGS. 1-7. As described previous herein thisspecification, the image of tissue displayed on a screen, such as thescreen 19 of FIG. 1, may be re-oriented to maintain the “up” positionthrough communication with an orientation sensor. In certainembodiments, the screen may be re-oriented manually through the use ofbuttons. For example, on a square and/or circular screen, 4 buttons maybe placed around the screen in at the top, bottom, left, and right. Bypressing a button, the user may re-orient the screen to make the side ofthe screen where the button is pressed, now become the top of the screenor the “up” position. In this manner, a user may ensure that the screenis always facing in a desirable direction. In certain embodiments, asdepicted in FIG. 17, such buttons 3402 may be positioned on thehandpiece 3400 so that the user may press a button to rotate the image45 degrees, 90 degrees, 135 degrees, 180 degrees, 225 degrees, 270degrees, or 315 degrees to orient the screen in a desired position. Suchbuttons may be spaced 90 degrees apart and be located at the top, left,right and bottom of the handpiece as shown in the figure. An LED may beused to denote the active button and the current “up” position. Incertain embodiments, there may be 1 button, 2 buttons, 3 buttons, 4buttons, 6 buttons, 8 buttons or or more than 8 buttons to re-orient thescreen. In certain embodiments, such as with a circular image, thescreen may be configured to only rotate 45 degrees per button press.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example described inthis section or elsewhere in this specification unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The protection is notrestricted to the details of any foregoing embodiments. The protectionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

While certain embodiments have been described, these embodiments havebeen presented by way of example only, and are not intended to limit thescope of protection. Indeed, the novel methods and systems described inthis section or elsewhere in this specification may be embodied in avariety of other forms. Furthermore, various omissions, substitutionsand changes in the form of the methods and systems described in thissection or elsewhere in this specification may be made. Those skilled inthe art will appreciate that in some embodiments, the actual steps takenin the processes illustrated and/or disclosed may differ from thoseshown in the figures. Depending on the embodiment, certain of the stepsdescribed above may be removed, others may be added. Furthermore, thefeatures and attributes of the specific embodiments disclosed above maybe combined in different ways to form additional embodiments, all ofwhich fall within the scope of the present disclosure.

Although the present disclosure includes certain embodiments, examplesand applications, it will be understood by those skilled in the art thatthe present disclosure extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and obviousmodifications and equivalents thereof, including embodiments which donot provide all of the features and advantages set forth in this sectionor elsewhere in this specification. Accordingly, the scope of thepresent disclosure is not intended to be limited by the specificdisclosures of preferred embodiments in this section or elsewhere inthis specification, and may be defined by claims as presented in thissection or elsewhere in this specification or as presented in thefuture.

What is claimed is:
 1. A sterilized, integrated, one time use disposablevisualization needle, comprising: an elongate tubular needle, extendingalong a longitudinal axis between a proximal end affixed to a handpieceand a distal end having a sharpened tip; an elongate optical elementextending through the needle, the elongate optical element comprising aproximal end and a distal end; wherein the elongate optical elementcomprises: a first segment comprising a first deflection in a firstdirection, a second segment comprising a second deflection in a seconddirection, and a third segment comprising a third deflection in thefirst direction; and wherein the first deflection, the seconddeflection, and the third deflection are configured to bias the distalend of the elongate optical element against the sharpened tip.
 2. Thevisualization needle of claim 1, wherein the first deflection is locatedat a position about 50-90% of the length of the elongate optical elementin a direction distal to the handpiece.
 3. The visualization needle ofclaim 2, wherein the first deflection is located at a position about 70%of the length of the elongate optical element in a direction distal tothe handpiece.
 4. The visualization needle of claim 2, wherein the firstdeflection is located at a position about 80% of the length of theelongate optical element in a direction distal to the handpiece.
 5. Thevisualization needle of claim 2, wherein the first deflection is locatedat a position about 90% of the length of the elongate optical element ina direction distal to the handpiece.
 6. The visualization needle ofclaim 1, wherein the first deflection comprises a degree of bending ofabout 1-35 degrees.
 7. The visualization needle of claim 6, wherein thefirst deflection comprises a degree of bending of about 5-10 degrees. 8.The visualization needle of claim 1, wherein the bias is configured toprovide blunting of the sharpened tip, the blunting configured toprevent damage to a tissue site.
 9. The visualization needle of claim 1,further comprising an image sensor positioned at the distal end of theelongate optical element.
 10. A sterilized, integrated, one time usedisposable visualization needle, comprising: an elongate tubular needle,extending along a longitudinal axis between a proximal end affixed to ahandpiece and a distal end having a sharpened tip; an elongate opticalelement extending through the needle, the elongate optical elementcomprising a proximal end and a distal end; wherein the elongate opticalelement comprises a first bend and a linear segment, the linear segmentlocated distal to the first bend; and wherein the first bend isconfigured to bias the elongate optical element against the sharpenedtip.
 11. The visualization needle of claim 10, wherein the linearsegment comprises about 10 to 40% of the length of the elongate opticalelement.
 12. The visualization needle of claim 11, wherein the linearsegment comprises about 20%-30% of the length of the elongate opticalelement.
 13. The visualization needle of claim 10, wherein the firstbend comprises a degree of bending of about 1-35 degrees.
 14. Thevisualization needle of claim 10, wherein the first bend comprises adegree of bending of about 5-10 degrees.
 15. The visualization needle ofclaim 10, wherein the bias is configured to provide blunting of thesharpened tip, the blunting configured to prevent damage to a tissuesite.
 16. The visualization need of claim 15, wherein the sharpened tipcomprises a reverse grind.
 17. The visualization needle of claim 10,further comprising an image sensor positioned at the distal end of theelongate optical element.
 18. The visualization needle of claim 10,wherein the elongate optical element comprises a second bend, the secondbend positioned distal to the first bend.
 19. The visualization needleof claim 18, wherein the elongate optical element comprises a thirdbend, the third bend positioned distal to the second bend.
 20. Thevisualization needle of claim 10, wherein the distal end of the elongateoptical element is configured to provide illumination.